BIRTH CONTROL METHODS

PRICING INFO


References:

Drug Dosage form Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Depo-Provera®

(medroxyprogesterone
acetate)
Vial
  • 150 mg/ml (1 ml)

Prefilled syringe
  • 150 mg/ml (1 ml syringe)
Dosage
  • 150 mg IM every 13 weeks
  • Injection should be given in the gluteal or deltoid muscle

Timing
  • Normal - the first injection should be given ONLY during the first 5 days of a normal menstrual period
  • After childbirth - may be initiated immediately after childbirth including women who are breastfeeding [6]
  • Switching from OCPs - patients switching from oral contraceptives should have their first injection of medroxyprogesterone on the day after the last active tablet or at the latest, on the day following the final inactive tablet
  • Late injections - if the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug
YES/1 dose: $-$$
  • Pregnancy after discontinuation - in one study, the median time to conception after the last dose of medroxyprogesterone was 10 months (range 4 - 31 months). Achieving conception was unrelated to duration of use.
Mechanism
  • Medroxyprogesterone acetate when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect

Efficacy

    Unintended pregnancy within first year of use:
    • Perfect use - 0.30%
    • Typical use - 3.0% [5]
Side effects (incidence > 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Weight gain (> 10 lbs at 24 months) - 38%
    • Headache - 17%
    • Abdominal pain - 11%
    • Nervousness - 11%
    • Dizziness - 6%
    • Decreased libido - 6%

Menstrual bleeding effects

  • Amenorrhea (no menses)
    • After 1 year - 55%
    • After 2 years - 68%
  • Irregular bleeding
    • After 1 year - 57%
    • After 2 years - 34%
  • CYP3A4 inducers - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • Antibiotics - There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. See oral contraceptives and antibiotics for more.
  • Loss of Bone Mineral Density (BMD) - medroxyprogesterone suppresses estrogen levels and is associated with a significant loss of BMD. It is unknown if use of medroxyprogesterone by younger women will reduce peak bone mass and increase the risk for osteoporotic fractures later in life. Medroxyprogesterone should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.
  • Thromboembolism (blood clots) - there have been reports of thromboembolic events in women taking medroxyprogesterone. A causal link between medroxyprogesterone and thromboembolism has not been established.
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between medroxyprogesterone use and breast cancer has not been established.
  • Lactation - medroxyprogesterone appears to be safe in breastfeeding
  • Fluid retention - medroxyprogesterone may cause fluid retention in susceptible patients
  • Accidental pregnancy exposure - in studies, medroxyprogesterone has not been harmful to a developing fetus
  • Coagulation tests - values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase with medroxyprogesterone use
  • Liver disease - should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
depo-subQ provera 104™

(medroxyprogesterone
acetate)
Prefilled syringe
  • 104 mg/0.65 ml
Dosage
  • 104 mg subcutaneously (sub-Q) every 12 - 14 weeks
  • Injection should be given in the anterior thigh or abdomen

Timing
  • Normal - the first injection should be given ONLY during the first 5 days of a normal menstrual period
  • After childbirth - may be initiated immediately after childbirth including women who are breastfeeding [6]
  • Switching from OCPs, patch, or ring - within 7 days after taking the last active pill, removing the patch, or removing the ring
  • Switching from Depo-Provera IM - give when next Depo-Provera IM shot is due
  • Late injections - if the time interval between injections is greater than 14 weeks, the physician should determine that the patient is not pregnant before administering the drug
NO/1 dose: $$$
  • Return to ovulation after stopping - in one study, the median time to ovulation was 10 months after last injection (range 6 - >12 months; 80% ovulated within 1 year). Ovulation has occurred as early as 14 weeks after a single injection.

  • Do not refrigerate. Store at room temperature
Mechanism
  • Medroxyprogesterone acetate when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect

Efficacy

    In three clinical studies, no pregnancies were detected among 2,042 women using depo-subQ provera 104™ for up to 1 year [1]
Side effects (incidence > 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Headache - 9%
    • Weight gain - 6% (average weight gain after 1 year - 3.5 lbs)
    • Injection site reactions - 5%

Menstrual bleeding effects

  • Amenorrhea (no menses)
    • After 6 months - 39%
    • After 1 year - 57%
  • Irregular bleeding
    • After 6 months - 13%
    • After 1 year - 10%
  • CYP3A4 inducers - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • Antibiotics - There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. See oral contraceptives and antibiotics for more.
  • Loss of Bone Mineral Density (BMD) - medroxyprogesterone suppresses estrogen levels and is associated with a significant loss of BMD. It is unknown if use of medroxyprogesterone by younger women will reduce peak bone mass and increase the risk for osteoporotic fractures later in life. Medroxyprogesterone should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.
  • Thromboembolism (blood clots) - There have been reports of thromboembolic events in women taking medroxyprogesterone. A causal link between medroxyprogesterone and thromboembolism has not been established.
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between medroxyprogesterone use and breast cancer has not been established.
  • Lactation - medroxyprogesterone appears to be safe in breastfeeding
  • Fluid retention - medroxyprogesterone may cause fluid retention in susceptible patients
  • Accidental pregnancy exposure - in studies, medroxyprogesterone has not been harmful to a developing fetus
  • Anaphylaxis - serious anaphylactic reactions have occurred in women receiving depo-subQ provera
  • Coagulation tests - values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase with medroxyprogesterone use
  • Liver disease - should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Ortho Evra® patch

Xulane™ patch

(norelgestromin and
ethinyl estradiol)
  • Each beige patch contains 6 mg norelgestromin and 0.75 mg ethinyl estradiol
  • Patch releases 0.035 mg of ethinyl estradiol and 0.150 mg of norelgestromin per 24 hours
  • Comes in a box that contains 3 patches
Dosage
  • Apply one patch each week for 3 weeks, followed by one week with no patch
  • Apply new patch on the same day of the week
  • Only wear one patch at a time
  • Apply patch on the upper outer arm, abdomen, buttock or back in a place where it won't be rubbed by tight clothing

Timing
  • First Day Start - the woman should apply her first patch during the first 24 hours of her menstrual period
  • Sunday Start - the woman should apply her first patch on the first Sunday after her menstrual period begins. With this option, a nonhormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only.
  • Switching from pill/ring - start patch on the day that a new cycle of pills or ring would be started
  • After childbirth - see CDC recommendations for combined birth control methods after childbirth
Ortho Evra®
1 month: $$$
Xulane™ (generic)
1 month: $-$$
  • Do not cut or alter patch

  • Do not apply patch to breasts

  • Do not apply patch in same location as last patch

  • Make sure skin is dry and clean before applying

  • Do not apply over lotions, creams, oils, or makeup
Mechanism
    Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation)

Efficacy
    In 3 trials involving 3330 women (21,155 cycles), the annual pregnancy rate was 1.07%. The pregnancy rate for women with a baseline body weight ≥ 198 lbs (90 kg), was significantly higher.
Side effects (incidence > 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Breast symptoms - 22%
    • Headache - 21%
    • Skin reactions to patch - 17%
    • Nausea - 17%
    • Pain during menses - 8%
    • Abdominal pain - 8%
    • Mood disorders - 6%

Menstrual bleeding effects
  • Breakthrough bleeding
    • After 1 cycle - 18%
    • After 1 year - 6%
  • Technivie® (ombitasvir, paritaprevir, and ritonavir) - DO NOT COMBINE. Drugs with ethinyl estradiol should not be taken with the hepatitis C drug Technivie. ALT elevations > 5 - 20 ULN have been seen in some patients.
  • Viekira-Pak™/Viekira XR™ (ombitasvir, paritaprevir, ritonavir, and dasabuvir) - DO NOT COMBINE. Drugs with ethinyl estradiol should not be taken with the hepatitis C drug Viekira-Pak. ALT elevations > 5 - 20 ULN have been seen in some patients.
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase hormone levels.
  • Vitamin C (ascorbic acid) - may increase ethinyl estradiol levels
  • Acetaminophen (Tylenol®) - may increase ethinyl estradiol levels
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma hormone levels have been noted
  • Ortho Evra® patch is a combined hormonal contraceptive like most oral contraceptives. It may share similar drug interactions as oral contraceptives. See oral contraceptive interactions for more possible interactions.
  • Contraindications to the Ortho Evra® patch are the same as those for combined oral contraceptive pills. See contraindications to OCPs for a complete list.
  • Thromboembolism (blood clots) - combined hormonal contraceptives like the Ortho Evra® patch increase the risk for blood clots. In studies, the risk with Ortho Evra® has been similar to, or slightly higher than what is seen with combined oral contraceptive pills. The risk appears to be highest in the first year of use, and may also be higher when the patch is re-started after a break of 4 weeks or longer. The risk is still less than what is seen in pregnancy and postpartum.
  • Women weighing ≥ 198 lbs (90 kg) - may be less effective in preventing pregnancy. In trials, women who weighed ≥ 198 lbs had significantly higher pregnancy rates.
  • Uncontrolled hypertension - may raise blood pressure in some women
  • Gallbladder disease - may increase the risk of gallbladder disease or worsen existing disease
  • Cholesterol - may affect cholesterol levels in some women
  • Blood sugar - may affect blood sugar levels in some women
  • Severe or persistent headache - may need to discontinue Ortho Evra®
  • Accidental pregnancy exposure - in studies, hormonal contraceptives have not been shown to be harmful to a developing fetus
  • Thyroid studies - hormonal contraceptives may affect thyroid studies. See thyroid studies for more.
  • Skin changes - melasma (brownish pigmentation of the face) may occur in some patients while taking hormonal contraceptives.
  • Hereditary angioedema - exogenous estrogen may induce angioedema
  • Breastfeeding - estrogens may decrease milk production
  • Liver disease - should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form Dosage / Timing Generic / Price Other / Ring expulsion Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
NuvaRing®
vaginal ring

(etonogestrel and ethinyl estradiol)
  • When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use

  • Comes in a box that contains 1 ring
Dosage
  • Insert one ring in vagina
  • Ring should remain in place continuously for 3 weeks
  • Ring is removed for a one-week break, during which time a withdrawal bleed usually occurs
  • A new ring is inserted one week after the last ring was removed
  • New ring is inserted on the same day of the week as it was inserted in the previous cycle
  • Insert new ring even if menses has not stopped
  • If NuvaRing® has been left in place for up to one extra week (i.e., up to four weeks total), the woman will remain protected. NuvaRing® should be removed and the woman should insert a new ring after a one-week ring-free interval.

Timing
  • First Day Start - the woman should insert her first ring during the first 24 hours of her menstrual period
  • Other start - ring may also be inserted on days 2-5 of the menstrual cycle, but in this case a barrier method, such as male condoms with spermicide, should be used for the first seven days of NuvaRing® use in the first cycle.
  • Switching from combined contraceptive pill - if taking pill correctly, the woman may switch from her combined contraceptive pill to NuvaRing® on any day during the pill cycle
  • Progestin-only methods (pills, Depo-Provera®, Mirena®, Implanon™) - The woman may switch from the pills on any day; she should start using NuvaRing® on the day after she took her last pill. She should switch from the Implanon™ or the Mirena® on the day of its removal, and from Depo-Provera® on the day when the next injection would be due. In all of these cases, the woman should use an additional barrier method such as a male condom with spermicide, for the first seven days.
  • After childbirth - see CDC recommendations for combined birth control methods after childbirth
NO/1 month: $$-$$$
Other
  • Consult product insert for proper insertion technique
  • Water-based nonoxynol-9 spermicide gel and tampon use do not affect drug absorption from the NuvaRing®
  • If NuvaRing® breaks, it may slip out easier. Discard ring and replace with new ring.
  • Tampons do not affect the absorption of hormones from NuvaRing
  • Return to ovulation - In studies, most women return to ovulation and spontaneous menstrual cycles within a month after discontinuation

Ring expulsion
  • Outside of vagina < 3 hours - If ring is accidentally expelled, and left outside of the vagina for less than 3 hours, contraceptive efficacy is not reduced. Rinse ring with cool or lukewarm water and reinsert as soon as possible.
  • Outside of the vagina for ≥ 3 hours:
    • During weeks 1 and 2 - reinsert ring ASAP. Use barrier method for 7 days.
    • During week 3
      • Option 1 - discard ring. Insert new ring. This will start a new three-week use period. Use barrier method for 7 days.
      • Option 2 - insert new ring no later than 7 days from time ring was expelled. Use barrier method for 7 days. Option 2 should only be used if NuvaRing® was used for 7 days prior to the day it was expelled.
Mechanism
  • Combination hormonal contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation)

Efficacy
    In 3 trials involving 2356 women (23,515 cycles), the annual pregnancy rate was 1.28%. Women with BMI ≥ 30 were excluded from the studies.
Side effects (incidence > 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Vaginitis - 14%
    • Headache - 11%
    • Mood changes - 6%
    • Device expulsion/foreign body sensation/discomfort - 6%
    • Nausea/Vomiting - 6%
    • Vaginal discharge - 6%

Menstrual bleeding effects

  • Amenorrhea (no menses)
    • In studies, 0.3 - 3.8% of women did not have withdrawal bleeding in a given cycle
  • Breakthrough bleeding
    • During first year: 12%
  • Technivie® (ombitasvir, paritaprevir, and ritonavir) - DO NOT COMBINE. Drugs with ethinyl estradiol should not be taken with the hepatitis C drug Technivie. ALT elevations > 5 - 20 ULN have been seen in some patients.
  • Viekira-Pak™/Viekira XR™ (ombitasvir, paritaprevir, ritonavir, and dasabuvir) - DO NOT COMBINE. Drugs with ethinyl estradiol should not be taken with the hepatitis C drug Viekira-Pak. ALT elevations > 5 - 20 ULN have been seen in some patients.
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase hormone levels.
  • Vaginal antifungal creams (e.g. miconazole) - may increase levels of etonogestrel and ethinyl estradiol
  • Vitamin C (ascorbic acid) - may increase ethinyl estradiol levels
  • Acetaminophen (Tylenol®) - may increase ethinyl estradiol levels
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma hormone levels have been noted
  • NuvaRing® is a combined hormonal contraceptive like most oral contraceptives. It may share similar drug interactions as oral contraceptives. See oral contraceptive interactions for other possible interactions.
  • Contraindications to the NuvaRing® are the same as those for combined oral contraceptive pills. See contraindications to OCPs for a complete list.
  • Thromboembolism (blood clots) - combined hormonal contraceptives like the NuvaRing® increase the risk for blood clots. In studies, the risk with NuvaRing® has been similar to what is seen with combined oral contraceptive pills. The risk is still less than what is seen in pregnancy and postpartum.
  • Toxic shock syndrome (TSS) - TSS has been reported in some women using NuvaRing®. Some of these women were also using tampons with the NuvaRing®. A causal link between TSS and NuvaRing® has not been established.
  • Vaginal irritation - women who are susceptible to vaginal irritation or ulceration may not tolerate NuvaRing®
  • Uncontrolled hypertension - may raise blood pressure in some women
  • Gallbladder disease - may increase the risk of gallbladder disease or worsen existing disease
  • Cholesterol - may affect cholesterol levels in some women
  • Blood sugar - may affect blood sugar levels in some women
  • Severe or persistent headache - may need to discontinue NuvaRing®
  • Accidental pregnancy exposure - in studies, hormonal contraceptives have not been shown to be harmful to a developing fetus
  • Thyroid studies - hormonal contraceptives may affect thyroid studies. See thyroid studies for more.
  • Skin changes - melasma (brownish pigmentation of the face) may occur in some patients while taking hormonal contraceptives.
  • Hereditary angioedema - exogenous estrogen may induce angioedema
  • Breastfeeding - estrogens may decrease milk production
  • Liver disease - should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form / Studies Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Implanon™
implant

Nexplanon®
implant

(etonogestrel)
Dosage forms
    Implanon™
    • One Implanon™ package consists of a single implant containing 68 mg etonogestrel that is 4 cm in length and 2 mm in diameter
    • Implanon™ is not radiopaque and cannot be seen by X-ray or CT scan
    Nexplanon®
    • One Nexplanon® package consists of a single implant containing 68 mg etonogestrel and 15 mg of barium sulfate that is 4 cm in length and 2 mm in diameter, which is pre-loaded in the needle of a disposable applicator
    • Nexplanon® is radiopaque (visible on an X-ray)

Studies
Dosage
  • Implant is effective for up to 3 years
  • Insert subdermally at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus
  • Must be inserted by the expiration date stated on the packaging
  • In one study, 123 patients used the implant for 4 years with zero pregnancies. In the same study, 34 women used the implant for 5 years with zero pregnancies. [PubMed abstract]
  • In another study, 311 women used the implant for 4 years with zero pregnancies. In the same study, 204 women used the implant for 5 years with zero pregnancies. [PubMed abstract]
  • In another study, 291 women who had used Implanon® for 3 years were followed for an additional 2 years (444 additional woman-years of use). During years 4 and 5, no pregnancies occurred. [PubMed abstract]

Timing
  • No previous contraception - insert between day 1 and day 5 of menses (no backup contraception needed). If inserted at other time, use backup contraception for 7 days.
  • Switching from combined contraceptive pills/patch/ring - preferably inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of the removal of the vaginal ring or transdermal patch. At the latest, insert on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval. If deviate from this timing use backup method for 7 days
  • Switching from Depo-Provera® - insert on day next injection is due
  • Switching from progestin-only pill - insert on any day of the month
  • IUD - insert on same day of removal
  • After childbirth - may be inserted immediately after childbirth including women who are breastfeeding [6]
NO/1 implant: $$$$ Other
  • Implant should be felt under skin after insertion
  • New implant may be inserted in the same arm, and through the same incision from which the previous implant was removed
  • Providers must receive training on insertion

Pregnancy after discontinuation
  • Pregnancies have been observed in as little as 7 - 14 days after removal
Mechanism
  • The contraceptive effect of Nexplanon® and Implanon™ is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium

Efficacy
    In trials involving 923 women (22,889 cycles), the annual pregnancy rate was 0.38%. Women who weighed > 130% of their ideal body weight were excluded from studies.
Side effects (incidence > 7%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Headache - 25%
    • Vaginitis - 15%
    • Weight increase - 14% (In studies, 2.8 pounds after 1 year, 3.7 pounds after 2 years)
    • Acne - 14%
    • Breast pain - 13%
    • Abdominal pain - 11%
    • Pharyngitis - 11%
    • White vaginal discharge - 10%
    • Influenza-like symptoms - 8%
    • Dizziness - 7%
    • Painful menses - 7%
    • Back Pain - 7%
    • Emotional lability - 7%

Menstrual bleeding effects
  • The bleeding pattern experienced during the first three months of Implanon™ use is broadly predictive of the future bleeding pattern for many women
  • Infrequent (< 3 days per 90 days) - 34%
  • Amenorrhea (no bleeding in 90 days) - 22%
  • Prolonged (any bleeding episode lasting more than 14 days in 90 days) - 18%
  • Frequent (> 5 bleeding episodes in 90 days) - 7%
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase plasma levels of etonogestrel.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • See oral contraceptive drug interactions for a discussion of other possible drug interactions with Implanon™
  • Insertion complications - neural or vascular injury may occur if inserted too deeply. Injection site pain, bleeding, and infection may occur. Removal may be difficult or impossible in some cases.
  • Implant migration - implant migration into the vasculature, lung, and chest wall has been reported
  • Broken or bent implants - there have been reports of broken or bent implants. Broken or bent implants may release etonogestrel at a higher rate.
  • Thromboembolism (blood clots) - There have been reports of thromboembolic events in women using etonogestrel. A causal link between etonogestrel and thromboembolism has not been established.
  • Liver tumors - hormonal contraceptives have been associated with liver tumors in rare cases
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between etonogestrel use and breast cancer has not been established.
  • Obesity - etonogestrel may be less effective in obese women
  • Ovarian cysts - etonogestrel may cause ovarian cysts (up to 26% in some studies) [2]
  • Uncontrolled hypertension - may raise blood pressure in some women
  • Gallbladder disease - may increase the risk of gallbladder disease or worsen existing disease
  • Cholesterol - may affect cholesterol levels in some women
  • Blood sugar - may affect blood sugar levels in some women
  • Contact lenses - contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist
  • Thyroid studies - hormonal contraceptives may affect thyroid studies. See thyroid studies for more.
  • Lactation - etonogestrel is safe in breastfeeding after the fourth postpartum week
  • Fluid retention - etonogestrel may cause fluid retention in susceptible patients
  • Accidental pregnancy exposure - there is no evidence etonogestrel is harmful to a developing fetus
  • Liver disease - should not be used by women with significant liver disease and should be removed if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Kyleena® IUD

(levonorgestrel)
  • Kyleena (levonorgestrel-releasing intrauterine system) contains a total of 19.5 mg of levonorgestrel
Dosage
  • Kyleena is approved for the prevention of pregnancy for up to 5 years

Timing
  • Normal - Kyleena should be inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion. Back-up contraception is not needed when Kyleena is inserted as directed.
  • After childbirth or second trimester abortion
    • Package insert - postpone insertion a minimum of 6 weeks or until the uterus is fully involuted
    • CDC - immediate insertion after delivery is safe and does not appear to increase health risks associated with IUD use such as infection. During the early postpartum period, there is an increased risk of IUD expulsion. This risk should be weighed against the potential benefits (e.g. effectiveness, future compliance) of early insertion on a patient-to-patient basis. [8]
NO/1 IUD: $$$$
Follow-up
  • Examine for Kyleena threads 4 - 6 weeks after insertion and yearly thereafter
  • If threads are not visible, verify location of Kyleena with ultrasound or X-ray (Kyleena is radiopaque)

Discontinuation
  • Women may become pregnant immediately after removal. Start alternative birth control method at least 7 days before removal if pregnancy is not desired. If woman has normal menses, may remove IUD and start new method during normal menses.
  • In one study, 71% of women wishing to become pregnant conceived within 12 months of Kyleena removal

MRI
  • Kyleena is safe during MRI under certain conditions:
    • Static magnetic field of 3 Tesla or less
    • Maximum spatial field gradient of 36,000 gauss/cm (360 T/m)
    • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4W/kg (First Level Controlled Operating Mode)
    • MRI quality may be compromised by artifact
  • Under the scan conditions defined above, the Kyleena is expected to produce a maximum temperature rise of less than 2° C after 15 minutes of continuous scanning

Indications for removal
  • Kyleena removal should be considered on an individual basis for the following conditions:
    • Coagulopathy or use of anticoagulants
    • Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
    • Exceptionally severe headache
    • Marked increase of blood pressure
    • Severe arterial disease such as stroke or myocardial infarction
    • Uterine or cervical malignancy
    • Jaundice
Mechanism
  • The local mechanism by which continuously released levonorgestrel enhances contraceptive effectiveness of Kyleena has not been conclusively demonstrated
  • Studies of levonorgestrel prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm function or survival, and alteration of the endometrium

Efficacy
    In one study involving 1452 women (57,313 cycles), the cumulative 5-year pregnancy rate was 1.45%
Side effects (incidence > 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Vulvovaginitis - 24%
    • Ovarian cysts - 22%
    • Acne - 14%
    • Headache - 13%
    • Abdominal pain - 13%
    • Pelvic pain - 8%
    • Dysmenorrhea - 8%
    • Increased bleeding - 8%
    • Breast pain - 7%

Menstrual bleeding effects
  • During the first 3 - 6 months of use, the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular.
  • Amenorrhea (no menses)
    • After 1 year - 12%
    • After 3 years - 20%
    • At the end of 5 years - 23%
  • Irregular bleeding
    • During first 90 days - 43%
    • During second 90 days - 25%
    • After 1 year - 17%
    • After 3 years - 10%
    • At the end of 5 years - 9%
  • The main contraceptive effect of Kyleena is through local effects on the uterine cavity. Some levonorgestrel is absorbed into the blood. It's unknown, but probably unlikely, that levonorgestrel-interacting drugs would have an effect on Kyleena's efficacy. It's unknown if levonorgestrel blood levels from Kyleena can affect other medications.
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase plasma levels of levonorgestrel.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • See oral contraceptive drug interactions for a discussion of other possible drug interactions with Kyleena
  • Emergency contraception - DO NOT USE for emergency contraception
  • Uterine anomalies that distort the uterine cavity - DO NOT USE
  • Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy - DO NOT USE
  • Postpartum endometritis or infected abortion in the past 3 months - DO NOT USE
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear - DO NOT USE
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between levonorgestrel use and breast cancer has not been established.
  • Uterine bleeding of unknown etiology - DO NOT USE
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled - DO NOT USE
  • Liver tumors - hormonal contraceptives have been associated with liver tumors in rare cases
  • Pelvic inflammatory disease (PID) - Kyleena may increase the risk of PID, particularly during the first month after insertion. PID is likely the result of bacteria introduced during insertion.
  • Pregnancy during Kyleena use - rule out ectopic pregnancy. If pregnancy is intrauterine, Kyleena should be removed. Removal or manipulation of Kyleena may result in pregnancy loss.
  • Group A streptococcal sepsis - rare cases have occurred
  • Actinomycosis - actinomycosis infection has been associated with IUD use
  • Embedment - embedment of Kyleena in the myometrium may occur. Embedment decreases effectiveness and may require surgical removal.
  • Perforation - perforation or penetration of the uterine wall or cervix may occur during insertion. Perforation may not be detected until some time later. Perforation may require surgery. Risk of perforation may be higher in lactating women. In trials, the risk of perforation in nonlactating women was < 0.1%.
  • Expulsion - IUD expulsion may occur. Expulsion may cause bleeding and pain, or it may be asymptomatic. In trials, the 5-year expulsion rate for Kyleena was 3.5%.
  • Ovarian cysts - Kyleena may cause ovarian cysts. In studies, 22% of women reported cysts while using Kyleena.
  • Lactation - Kyleena appears to be safe in breastfeeding
  • Liver disease - should not be used by women with significant liver disease and should be removed if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Liletta® IUD

(levonorgestrel)
  • Liletta® (levonorgestrel-releasing intrauterine system) contains a total of 52 mg of levonorgestrel.
Dosage
  • Liletta® is approved for the prevention of pregnancy for up to 4 years

Timing
  • Normal - Liletta® should be inserted within seven days of the onset of menstruation
  • Insertion outside of first 7 days of menses - patient should use barrier method for 7 days
  • Switching from pills, patch, and ring - may be inserted at any time. If inserted during active phase of other method, continue other method for 7 days after insertion.
  • Switching from injectable progestin - may be inserted at any time. Use barrier method for 7 days if inserted more than 13 weeks after last injection.
  • Switching from implant or other IUD - insert Liletta® on the same day as the removal of other device
  • After childbirth
    • Package insert - postpone insertion a minimum of 6 weeks or until the uterus is fully involuted
    • CDC - immediate insertion after delivery is safe and does not appear to increase health risks associated with IUD use such as infection. During the early postpartum period, there is an increased risk of IUD expulsion. This risk should be weighed against the potential benefits (e.g. effectiveness, future compliance) of early insertion on a patient-to-patient basis. [8]
NO/1 IUD: $$$$
Follow-up
  • Examine for Liletta® threads 4 - 6 weeks after insertion and yearly thereafter
  • If threads are not visible, verify location of Liletta® with ultrasound or X-ray (Liletta® is radiopaque)

Discontinuation
  • Women may become pregnant immediately after Liletta® removal. Start alternative birth control method at least 7 days before removal if pregnancy is not desired. If woman has normal menses, may remove IUD and start new method during normal menses.
  • In one study, of 68 women who desired pregnancy after Liletta removal, 71% conceived within 6 months and 87% conceived within 12 months

MRI
  • Liletta® is MRI safe

Indications for removal
  • Liletta® removal should be considered on an individual basis for the following conditions:
    • Coagulopathy or use of anticoagulants
    • Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
    • Exceptionally severe headache
    • Marked increase of blood pressure
    • Severe arterial disease such as stroke or myocardial infarction
    • Uterine or cervical malignancy
    • Jaundice
Mechanism
  • The local mechanism by which continuously released levonorgestrel enhances contraceptive effectiveness of Liletta® has not been conclusively demonstrated
  • Studies of levonorgestrel prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm function and survival, and alteration of the endometrium

Efficacy
    In one study involving 1910 women (34,711 cycles), the cumulative 3-year pregnancy rate was 0.55%
Side effects (incidence > 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Vaginal infections - 13.6%
    • Vulvovaginal infections - 13.3%
    • Acne - 12.3%
    • Headache/migraine - 9.8%
    • Nausea/vomiting - 7.9%
    • Pain during intercourse - 7%
    • Abdominal pain - 6.8%
    • Breast pain - 6.7%
    • Pelvic pain - 6.1%
    • Depressed mood - 5.4%
    • Mood changes - 5.2%

Menstrual bleeding effects
  • During the first 3 - 6 months of use, the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular.
  • Amenorrhea (no menses)
    • After 1 year - 19%
    • After 2 years - 26%
    • After 3 years - 38%
  • Average # of bleeding/spotting days per cycle
    • After 1 year - 4 days
    • After 2 years - 3 days
  • The main contraceptive effect of Liletta is through local effects on the uterine cavity. Some levonorgestrel is absorbed into the blood. It's unknown, but probably unlikely, that levonorgestrel-interacting drugs would have an effect on Liletta's efficacy. It's unknown if levonorgestrel blood levels from Liletta can affect other medications.
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase plasma levels of levonorgestrel.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • See oral contraceptive drug interactions for a discussion of other possible drug interactions with Liletta®
  • Emergency contraception - DO NOT USE for emergency contraception
  • Uterine anomalies that distort the uterine cavity - DO NOT USE
  • Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy - DO NOT USE
  • Postpartum endometritis or infected abortion in the past 3 months - DO NOT USE
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear - DO NOT USE
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between levonorgestrel use and breast cancer has not been established.
  • Uterine bleeding of unknown etiology - DO NOT USE
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled - DO NOT USE
  • Liver tumors - hormonal contraceptives have been associated with liver tumors in rare cases
  • Pelvic inflammatory disease (PID) - IUDs may increase the risk of PID, particularly after insertion. PID is likely the result of bacteria introduced during insertion. If PID occurs with Liletta in place, removal of Liletta may not be necessary if woman responds to treatment.
  • Pregnancy during Liletta use - rule out ectopic pregnancy. If pregnancy is intrauterine, Liletta should be removed. Removal or manipulation of Liletta may result in pregnancy loss.
  • Group A streptococcal sepsis - rare cases have occurred
  • Actinomycosis - actinomycosis infection has been associated with IUD use
  • Perforation - perforation or penetration of the uterine wall or cervix may occur during insertion. Perforation may not be detected until some time later. Perforation may require surgery. The risk of perforation may be increased in lactating women. In trials, the incidence of perforation in nonlactating women was 0.1%.
  • Expulsion - IUD expulsion may occur. Expulsion may cause bleeding and pain, or it may be asymptomatic. In Liletta trials, expulsion occurred in 2% of nulliparous women and 5.6% of parous women.
  • Ovarian cysts - Liletta may cause ovarian cysts. In trials, symptomatic cysts occurred in 3.4% of women.
  • Embedment - embedment of Liletta in the myometrium may occur. Embedment decreases effectiveness and may require surgical removal.
  • Lactation - Liletta appears to be safe in breastfeeding
  • Obesity - body weight does not appear to affect the efficacy of Liletta
  • Liver disease - should not be used by women with significant liver disease and should be removed if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form / Studies Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Mirena® IUD

(levonorgestrel)
Dosage form
  • Mirena® (levonorgestrel-releasing intrauterine system) contains a total of 52 mg of levonorgestrel

Studies
Dosage
  • Mirena® is approved for the prevention of pregnancy for up to 5 years
  • In one study, 263 women used Mirena® for a median of 11.7 months past the fifth year, and only one pregnancy occurred [PubMed abstract]
  • In another study, 398 women used Mirena® for 7 continuous years and no pregnancies occurred after year 5. In the same study, no pregnancies occurred in 681 women-years of use from years 8 - 11. [PubMed abstract]
  • In another study, 496 women who had used Mirena® for 5 years were followed for an additional 2 years (697 additional woman-years of use). During years 6 and 7, only two pregnancies occurred. [PubMed abstract]

Timing
  • Normal - Mirena® should be inserted within seven days of the onset of menstruation or immediately after a first trimester abortion
  • After childbirth
    • Package insert - postpone insertion a minimum of 6 weeks or until the uterus is fully involuted
    • CDC - immediate insertion after delivery is safe and does not appear to increase health risks associated with IUD use such as infection. During the early postpartum period, there is an increased risk of IUD expulsion. This risk should be weighed against the potential benefits (e.g. effectiveness, future compliance) of early insertion on a patient-to-patient basis. [8]
NO/1 IUD: $$$$
Follow-up
  • Examine for Mirena® threads 4 - 6 weeks after insertion and yearly thereafter
  • If threads are not visible, verify location of Mirena® with ultrasound or X-ray (Mirena® is radiopaque)

Discontinuation
  • Women may become pregnant immediately after Mirena® removal. Start alternative birth control method at least 7 days before removal if pregnancy is not desired. If woman has normal menses, may remove IUD and start new method during normal menses.
  • In trials, about 80% of women who wished to become pregnant conceived within 12 months of Mirena removal

Indications for removal
  • Mirena® removal should be considered on an individual basis for the following conditions:
    • New-onset bleeding causing anemia
    • Sexually transmitted diseases
    • Pelvic infection; endometritis
    • Symptomatic genital actinomycosis
    • Intractable pelvic pain
    • Severe pain during intercourse
    • Migraine with vision loss
    • Arterial disease (CAD and PVD)

Other FDA-approved indications
  • Mirena® is also approved for the treatment of heavy menstrual bleeding in women who choose to use intrauterine contraception as their method of contraception
Mechanism
  • The local mechanism by which continuously released levonorgestrel enhances contraceptive effectiveness of Mirena® has not been conclusively demonstrated
  • Studies of Mirena® prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium
  • Ovulation is inhibited in some women using Mirena®. In a 1-year study, approximately 45% of menstrual cycles were ovulatory. In another study, after 4 years, 75% of cycles were ovulatory.

Efficacy
    In two trials involving 1169 women (45,000 cycles), the cumulative 5-year pregnancy rate was 0.7%
Side effects (incidence ≥ 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Abdominal/pelvic pain - 13%
    • Ovarian cysts - 12%
    • Headache/migraine - 8%
    • Acne - 7%
    • Depressed/altered mood - 6%
    • Heavy menstrual bleeding - 6%
    • Breast pain - 5%
    • Vaginal discharge - 5%
    • IUD expulsion - 5%

Menstrual bleeding effects
  • During the first 3 - 6 months of use, the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular.
  • Amenorrhea (no menses)
    • After 1 year - 20%
  • The main contraceptive effect of Mirena® is through local effects on the uterine cavity. Some levonorgestrel is absorbed into the blood. It's unknown, but probably unlikely, that levonorgestrel-interacting drugs would have an effect on Mirena's efficacy. It's unknown if levonorgestrel blood levels from Mirena® can affect other medications.
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase plasma levels of levonorgestrel.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • See oral contraceptive drug interactions for a discussion of other possible drug interactions with Mirena®
  • Emergency contraception - DO NOT USE for emergency contraception
  • Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy - DO NOT USE
  • Postpartum endometritis or infected abortion in the past 3 months - DO NOT USE
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear - DO NOT USE
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled - DO NOT USE
  • Uterine anomalies that distort the uterine cavity - DO NOT USE
  • Liver tumors - hormonal contraceptives have been associated with liver tumors in rare cases
  • Pregnancy during Mirena® use - rule out ectopic pregnancy. If pregnancy is intrauterine, Mirena® should be removed. Removal or manipulation of Mirena® may result in pregnancy loss.
  • Group A streptococcal sepsis - rare cases have occurred
  • Pelvic inflammatory disease (PID) - Mirena® increases the risk of PID, particularly during the first 20 days after insertion. PID is likely the result of bacteria introduced during insertion.
  • Embedment -embedment of Mirena® in the myometrium may occur. Embedment decreases effectiveness and may require surgical removal.
  • Perforation - perforation or penetration of the uterine wall or cervix may occur during insertion. Perforation may not be detected until some time later. Perforation may require surgery. The risk of perforation is increased in lactating women. In one study, the incidence of perforation was 6.3 per 1000 insertions for lactating women, compared to 1.0 per 1000 insertions for non-lactating women.
  • Expulsion - IUD expulsion may occur. Expulsion may cause bleeding and pain, or it may be asymptomatic. In trials, the risk of expulsion was 4.5% over 5 years.
  • Ovarian cysts - Mirena® may cause ovarian cysts. In trials, ovarian cysts were reported in 8% of Mirena users.
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between levonorgestrel use and breast cancer has not been established.
  • Blood sugar - may affect blood sugar levels in some women
  • Uncontrolled hypertension - may raise blood pressure in some women
  • Severe or persistent headache - use caution. May need to remove
  • Lactation - Mirena® appears to be safe in breastfeeding
  • Liver disease - should not be used by women with significant liver disease and should be removed if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
Skyla® IUD

(levonorgestrel)
  • Skyla (levonorgestrel-releasing intrauterine system) contains a total of 13.5 mg of levonorgestrel
Dosage
  • Skyla is approved for the prevention of pregnancy for up to 3 years

Timing
  • Normal - Skyla should be inserted within seven days of the onset of menstruation or immediately after a first trimester abortion
  • After childbirth
    • Package insert - postpone insertion a minimum of 6 weeks or until the uterus is fully involuted
    • CDC - immediate insertion after delivery is safe and does not appear to increase health risks associated with IUD use such as infection. During the early postpartum period, there is an increased risk of IUD expulsion. This risk should be weighed against the potential benefits (e.g. effectiveness, future compliance) of early insertion on a patient-to-patient basis. [8]
NO/1 IUD: $$$$
Follow-up
  • Examine for Skyla threads 4 - 6 weeks after insertion and yearly thereafter
  • If threads are not visible, verify location of Skyla with ultrasound or X-ray (Skyla is radiopaque)

Discontinuation
  • Women may become pregnant immediately after removal. Start alternative birth control method at least 7 days before removal if pregnancy is not desired. If woman has normal menses, may remove IUD and start new method during normal menses.
  • In one study, 77% of women wishing to become pregnant conceived within 12 months of Skyla removal

MRI
  • Skyla is safe during MRI under certain conditions:
    • Static magnetic field of 3 Tesla or less
    • Spatial gradient field of 36,000 Gauss/cm (T/m) or less
    • Maximum whole body averaged specific absorption rate (SAR) of 4W/kg in the First Level Controlled mode for 15 minutes of continuous scanning
    • MRI quality may be compromised by artifact

Indications for removal
  • Skyla removal should be considered on an individual basis for the following conditions:
    • Coagulopathy or use of anticoagulants
    • Migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia
    • Exceptionally severe headache
    • Marked increase of blood pressure
    • Severe arterial disease such as stroke or myocardial infarction
    • Uterine or cervical malignancy
    • Jaundice
Mechanism
  • The local mechanism by which continuously released levonorgestrel enhances contraceptive effectiveness of Skyla has not been conclusively demonstrated
  • Studies of levonorgestrel prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm function or survival, and alteration of the endometrium

Efficacy
    In one trial involving 1432 women (39,368 cycles), the cumulative 3-year pregnancy rate was 0.9%
Side effects (incidence ≥ 5%)
  • NOTE: Strength of association is unknown. Placebo-control is not used in contraceptive trials.
    • Vulvovaginitis - 20%
    • Acne - 13.6%
    • Ovarian cysts - 13%
    • Abdominal pain - 12.7%
    • Headache - 12.4%
    • Painful menses - 8.6%
    • Increased menstrual bleeding - 7.8%
    • Pelvic pain - 6.2%
    • Nausea - 5.5%
    • Breast pain - 5.3%

Menstrual bleeding effects
  • During the first 3 - 6 months of use, the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter the number of bleeding and spotting days usually decreases but bleeding may remain irregular.
  • Amenorrhea (no menses)
    • After 1 year - 6%
    • After 3 years - 12%
  • Irregular bleeding
    • After 1 year - 23%
    • After 3 years - 17%
  • The main contraceptive effect of Skyla is through local effects on the uterine cavity. Some levonorgestrel is absorbed into the blood. It's unknown, but probably unlikely, that levonorgestrel-interacting drugs would have an effect on Skyla's efficacy. It's unknown if levonorgestrel blood levels from Skyla can affect other medications.
  • CYP3A4 inducers and inhibitors - CYP3A4 inducers may decrease the effectiveness of contraceptive hormones. Use additional or alternative birth control methods while taking concurrently. CYP3A4 inhibitors may increase plasma levels of levonorgestrel.
  • HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors - increases and decreases in plasma progestin levels have been noted
  • See oral contraceptive drug interactions for a discussion of other possible drug interactions with Skyla
  • Emergency contraception - DO NOT USE for emergency contraception
  • Uterine anomalies that distort the uterine cavity - DO NOT USE
  • Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy - DO NOT USE
  • Postpartum endometritis or infected abortion in the past 3 months - DO NOT USE
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear - DO NOT USE
  • Breast cancer - women who currently have or have had breast cancer should not use hormonal contraceptives. A definitive link between levonorgestrel use and breast cancer has not been established.
  • Uterine bleeding of unknown etiology - DO NOT USE
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled - DO NOT USE
  • Liver tumors - hormonal contraceptives have been associated with liver tumors in rare cases
  • Pelvic inflammatory disease (PID) - Skyla may increase the risk of PID, particularly during the first month after insertion. PID is likely the result of bacteria introduced during insertion.
  • Pregnancy during Skyla use - rule out ectopic pregnancy. If pregnancy is intrauterine, Skyla should be removed. Removal or manipulation of Skyla may result in pregnancy loss.
  • Group A streptococcal sepsis - rare cases have occurred
  • Actinomycosis - actinomycosis infection has been associated with IUD use
  • Embedment -embedment of Skyla in the myometrium may occur. Embedment decreases effectiveness and may require surgical removal.
  • Perforation - perforation or penetration of the uterine wall or cervix may occur during insertion. Perforation may not be detected until some time later. Perforation may require surgery. Risk of perforation may be higher in lactating women. In trials, the incidence of perforation in nonlactating women was < 0.1%.
  • Expulsion - IUD expulsion may occur. Expulsion may cause bleeding and pain, or it may be asymptomatic. In trials, the 3-year expulsion rate for Skyla was 3.2%.
  • Ovarian cysts - Skyla may cause ovarian cysts. In studies, 13.2% of women had cysts while using Skyla.
  • Lactation - Skyla appears to be safe in breastfeeding
  • Liver disease - should not be used by women with significant liver disease and should be removed if jaundice or disturbances of liver function occur
  • Kidney disease - has not been studied
Drug Dosage form / Studies Dosage / Timing Generic / Price Other Mechanism of Action / Efficacy Side Effects / Menstrual bleeding effects Drug Interactions Precautions / Contraindications
ParaGard® T 380A
IUD

(copper)
Dosage form
  • ParaGard® is a T-shaped intrauterine device (IUD) measuring 32mm horizontally and 36mm vertically
  • ParaGard® contains copper: approximately 176 mg of wire coiled along the vertical stem and a 68.7 mg collar on each side of the horizontal arm

Studies
Dosage
  • ParaGard® is approved for the prevention of pregnancy for up to 10 years

Timing
  • Normal - ParaGard® may be placed at any time during the cycle when the clinician is reasonably certain the patient is not pregnant
  • After childbirth
    • Package insert - may be placed immediately after delivery, although risk of expulsion may be higher. If not inserted immediately postpartum, insertion should be delayed to the second postpartum month because insertion during the first postpartum month (except for immediately after delivery) has been associated with increased risk of perforation.
    • CDC - immediate insertion after delivery is safe and does not appear to increase health risks associated with IUD use such as infection. During the early postpartum period, there is an increased risk of IUD expulsion. This risk should be weighed against the potential benefits (e.g. effectiveness, future compliance) of early insertion on a patient-to-patient basis. [8]
  • After abortion - can be placed immediately after abortion, although immediate placement has a slightly higher risk of expulsion than placement at other times. Placement after second trimester abortion is associated with a higher risk of expulsion than placement after the first trimester abortion.
  • Emergency contraception - When inserted within five days of unprotected intercourse, a copper-bearing IUD is over 99% effective in preventing pregnancy. This is the most effective form of emergency contraception available. [4]
NO/1 IUD: $$$$
Follow-up
  • Following placement, examine the patient after her first menses to confirm that ParaGard® is still in place
  • If threads are not visible, verify location of ParaGard® with ultrasound or X-ray (ParaGard® is radiopaque)

Discontinuation
  • Women may become pregnant immediately after ParaGard® removal. Start alternative birth control method at least 7 days before removal if pregnancy is not desired.
  • In studies, 89% of women wishing to become pregnant conceived within 12 months of ParaGard removal

MRI
  • Limited data suggest that MRI at the level of 1.5 Tesla is acceptable in women using ParaGard

Copper levels
  • In studies, serum copper levels have risen slightly in ParaGard® users [3]

Indications for removal
  • ParaGard® removal should be considered on an individual basis for the following conditions:
    • New onset bleeding causing anemia
    • Sexually transmitted diseases
    • Pelvic infection; endometritis
    • Symptomatic genital actinomycosis
    • Intractable pelvic pain
    • Severe pain during intercourse
Mechanism
  • The contraceptive effectiveness of ParaGard® is enhanced by copper continuously released into the uterine cavity. Mechanism(s) by which copper enhances contraceptive efficacy include interference with sperm transport and fertilization of an egg, and possibly prevention of implantation.

Efficacy
    Unintended pregnancy within first year of use:
    • Perfect use - 0.60%
    • Typical use - 0.80%
Side effects (incidence not well-defined)
  • Bleeding/pain - 1st year - 12%; 5th year - 4%
  • Expulsion - 1st year - 6%; 5th year - 0.3%
  • Painful menses
  • Pain during intercourse
  • Anemia
  • Backache
  • White vaginal discharge
  • Urticarial allergic skin reaction
  • Vaginitis

Menstrual bleeding effects
  • ParaGard® does not stop normal menses
  • Menses may be heavier and longer in some women. This typically improves after 2 - 3 months of use.
  • The main contraceptive effect of ParaGard® is through local effects on the uterine cavity.
  • There are no known drug interactions with ParaGard®
  • Uterine anomalies that distort the uterine cavity - DO NOT USE
  • Acute pelvic inflammatory disease or a history of pelvic inflammatory disease unless there has been a subsequent intrauterine pregnancy - DO NOT USE
  • Postpartum endometritis or infected abortion in the past 3 months - DO NOT USE
  • Known or suspected uterine or cervical neoplasia or unresolved, abnormal Pap smear - DO NOT USE
  • Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled - DO NOT USE
  • Wilson's disease (copper transport disease) - DO NOT USE
  • Pregnancy during ParaGard® use - rule out ectopic pregnancy. If pregnancy is intrauterine, ParaGard® should be removed. Removal or manipulation of ParaGard® may result in pregnancy loss.
  • Pelvic inflammatory disease (PID) - ParaGard® increases risk (highest risk seen first 20 days after insertion)
  • Embedment -embedment of ParaGard® in the myometrium may occur. Embedment decreases effectiveness and may require surgical removal.
  • Perforation - perforation or penetration of the uterine wall or cervix may occur during insertion. Perforation may not be detected until some time later. Perforation may require surgery.
  • Expulsion - IUD expulsion may occur. Expulsion may cause bleeding and pain, or it may be asymptomatic. In trials, the incidence of expulsion was 6% during the first year, and 0.3% during the fifth year.
  • Lactation - nursing mothers may use ParaGard®. No difference has been detected in concentration of copper in human milk before and after insertion of copper IUDs.
  • MRI imaging - limited data suggest that MRI at the level of 1.5 Tesla is acceptable in women using ParaGard®
  • Medical diathermy - theoretically, diathermy may cause the IUD to heat up and damage tissue
  • Liver disease - has not been studied
  • Kidney disease - has not been studied