Progestin-Only Pills

Initiation of POPs

Timing

• POPs can be started at any time if it is reasonably certain that the woman is not pregnant (Box 2).

Need for Back-Up Contraception

• If POPs are started within the first 5 days since menstrual bleeding started, no additional contraceptive protection is needed.
• If POPs are started >5 days since menstrual bleeding started, the woman needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days.

Special Considerations

Amenorrhea (Not Postpartum)

• Timing: POPs can be started at any time if it is reasonably certain that the woman is not pregnant (Box 2).
• Need for back-up contraception: The woman needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days.

Postpartum (Breastfeeding)

• Timing: POPs can be started at any time, including immediately postpartum (U.S. MEC 2 if <1 month postpartum and U.S. MEC 1 if ≥1 month postpartum) if it is reasonably certain that the woman is not pregnant (Box 2).
• Need for back-up contraception: If the woman is <6 months postpartum, amenorrheic, and fully or nearly fully breastfeeding (exclusively breastfeeding or the vast majority [≥85%] of feeds are breastfeeds) (27), no additional contraceptive protection is needed. Otherwise, a woman who is ≥21 days postpartum and has not experienced return of her menstrual cycles, she needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days. If her menstrual cycles have returned and it has been >5 days since menstrual bleeding started, she needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days.

Postpartum (Not Breastfeeding)

• Timing: POPs can be started at any time, including immediately postpartum (U.S. MEC 1), if it is reasonably certain that the woman is not pregnant (Box 2).
• Need for back-up contraception: If a woman is <21 days postpartum, no additional contraceptive protection is needed. Women who are ≥21 days postpartum and whose menstrual cycles have not returned need to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days. If her menstrual cycles have returned and it has been >5 days since menstrual bleeding started, she needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days.

Postabortion (Spontaneous or Induced)

• Timing: POPs can be started within the first 7 days, including immediately postabortion (U.S. MEC 1).
• Need for back-up contraception: The woman needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days unless POPs are started at the time of a surgical abortion.

Switching from Another Contraceptive Method

• Timing: POPs can be started immediately if it is reasonably certain that the woman is not pregnant (Box 2). Waiting for her next menstrual period is unnecessary.
• Need for back-up contraception: If it has been >5 days since menstrual bleeding started, she needs to abstain from sexual intercourse or use additional contraceptive protection for the next 2 days.
• Switching from an IUD: If the woman has had sexual intercourse since the start of her current menstrual cycle and it has been >5 days since menstrual bleeding started, theoretically, residual sperm might be in the genital tract, which could lead to fertilization if ovulation occurs. A health-care provider may consider any of the following options:
  • Advise the women to retain the IUD for at least 2 days after POPs are initiated and return for IUD removal.
  • Advise the woman to abstain from sexual intercourse or use barrier contraception for 7 days before removing the IUD and switching to the new method.
  • If the woman cannot return for IUD removal and has not abstained from sexual intercourse or used barrier contraception for 7 days, advise the woman to use ECPs at the time of IUD removal. POPs can be started immediately after use of ECPs (with the exception of UPA). POPs can be started no sooner than 5 days after use of UPA.

Comments and Evidence Summary. In situations in which the health-care provider is uncertain whether the woman might be pregnant, the benefits of starting POPs likely exceed any risk; therefore, starting POPs should be considered at any time, with a follow-up pregnancy test in 2–4 weeks.

Unlike COCs, POPs inhibit ovulation in about half of cycles, although the rates vary widely by individual (279). Peak serum steroid levels are reached about 2 hours after administration, followed by rapid distribution and elimination, such that by 24 hours after administration, serum steroid levels are near baseline (279). Therefore, taking POPs at approximately the same time each day is important. An estimated 48 hours of POP use has been deemed necessary to achieve the contraceptive effects on cervical mucus (279). If a woman needs to use additional contraceptive protection when switching to POPs from another contraceptive method, consider continuing her previous method for 2 days after starting POPs. No direct evidence was found regarding the effects of starting POPs at different times of the cycle.

Examinations and Tests Needed Before Initiation of POPs

Among healthy women, no examinations or tests are needed before initiation of POPs, although a baseline weight and BMI measurement might be useful for monitoring POP users over time (Table 5). Women with known medical problems or other special conditions might need additional examinations or tests before being determined to be appropriate candidates for a particular method of contraception. U.S. MEC might be useful in such circumstances (5).

Comments and Evidence Summary. Weight (BMI): Obese women can use POPs (U.S. MEC 1) (5); therefore, screening for obesity is not necessary for the safe initiation of POPs. However, measuring weight and calculating BMI at baseline might be helpful for monitoring any changes and counseling women who might be concerned about weight change perceived to be associated with their contraceptive method.

Bimanual examination and cervical inspection: Pelvic examination is not necessary before initiation of POPs because it does not facilitate detection of conditions for which POPs would be unsafe. Women with current breast cancer should not use POPs (U.S. MEC 4), and women with certain liver diseases generally should not use POPs (U.S. MEC 3) (5); however, neither of these conditions are likely to be detected by pelvic examination (145). A systematic review identified two case-control studies that compared delayed versus immediate pelvic examination before initiation of hormonal contraceptives, specifically oral contraceptives or DMPA (95). No differences in risk factors for cervical neoplasia, incidence of STDs, incidence of abnormal Papanicolaou smears, or incidence of abnormal wet mounts were observed (Level of evidence: II-2 fair, direct).

Lipids: Screening for dyslipidemias is not necessary for the safe initiation of POPs because of the low prevalence of undiagnosed disease in women of reproductive age and the low likelihood of clinically significant changes with use of hormonal contraceptives. A systematic review did not identify any evidence regarding outcomes among women who were screened versus not screened with lipid measurement before initiation of hormonal contraceptives (57). During 2009–2012 among women aged 20–44 years in the United States, 7.6% had high cholesterol, defined as total serum cholesterol ≥240 mg/dL (84). During 1999–2008, the prevalence of undiagnosed hypercholesterolemia among women aged 20–44 years was approximately 2% (85). Studies have shown mixed results about the effects of hormonal methods on lipid levels among both healthy women and women with baseline lipid abnormalities, and the clinical significance of these changes is unclear (86–89).

Liver enzymes: Although women with certain liver diseases generally should not use POPs (U.S. MEC 3) (5), screening for liver disease before initiation of POPs is not necessary because of the low prevalence of these conditions and the high likelihood that women with liver disease already would have had the condition diagnosed. A systematic review did not identify any evidence regarding outcomes among women who were screened versus not screened with liver enzyme tests before initiation of hormonal contraceptives (57). In 2012, among U.S. women, the percentage with liver disease (not further specified) was 1.3% (90). In 2013, the incidence of acute hepatitis A, B, or C was ≤1 per 100,000 U.S. population (91). During 2002–2011, the incidence of liver carcinoma among U.S. women was approximately 3.7 per 100,000 population (92). Because estrogen and progestins are metabolized in the liver, the use of hormonal contraceptives among women with liver disease might, theoretically, be a concern. The use of hormonal contraceptives, specifically COCs and POPs, does not affect disease progression or severity in women with hepatitis, cirrhosis, or benign focal nodular hyperplasia (93,94).

Clinical breast examination: Although women with current breast cancer should not use POPs (U.S. MEC 4) (5), screening asymptomatic women with a clinical breast examination before initiating POPs is not necessary because of the low prevalence of breast cancer among women of reproductive age. A systematic review did not identify any evidence regarding outcomes among women who were screened versus not screened with a clinical breast examination before initiation of hormonal contraceptives (95). The incidence of breast cancer among women of reproductive age in the United States is low. In 2012, the incidence of breast cancer among women aged 20–49 years was approximately 70.7 per 100,000 women (96).

Other screening: Women with hypertension, diabetes, anemia, thrombogenic mutations, cervical intraepithelial neoplasia, cervical cancer, STDs, or HIV infection can use (U.S. MEC 1) or generally can use (U.S. MEC 2) POPs (5); therefore, screening for these conditions is not necessary for the safe initiation of POPs.

Number of Pill Packs that Should Be Provided at Initial and Return Visits

• At the initial and return visits, provide or prescribe up to a 1-year supply of POPs (e.g., 13 28-day pill packs), depending on the woman’s preferences and anticipated use.
• A woman should be able to obtain POPs easily in the amount and at the time she needs them.

Comments and Evidence Summary. The more pill packs given up to 13 cycles, the higher the continuation rates. Restricting the number of pill packs distributed or prescribed can result in unwanted discontinuation of the method and increased risk for pregnancy.

A systematic review of the evidence suggested that providing a greater number of pill packs was associated with increased continuation (232). Studies that compared provision of one versus 12 packs, one versus 12 or 13 packs, or three versus seven packs found increased continuation of pill use among women provided with more pill packs (233–235). However, one study found that there was no difference in continuation when patients were provided one and then three packs versus four packs all at once (236). In addition to continuation, a greater number of pill packs provided was associated with fewer pregnancy tests, fewer pregnancies, and lower cost per client. However, a greater number of pill packs (13 packs versus three packs) also was associated with increased pill wastage in one study (234) (Level of evidence: I to II-2, fair, direct).

Routine Follow-Up After POP Initiation

These recommendations address when routine follow-up is recommended for safe and effective continued use of contraception for healthy women. The recommendations refer to general situations and might vary for different users and different situations. Specific populations that might benefit from more frequent follow-up visits include adolescents, those with certain medical conditions or characteristics, and those with multiple medical conditions.

• Advise a woman to return at any time to discuss side effects or other problems or if she wants to change the method being used. No routine follow-up visit is required.
• At other routine visits, health-care providers seeing POP users should do the following:
  • Assess the woman’s satisfaction with her contraceptive method and whether she has any concerns about method use.
  • Assess any changes in health status, including medications, that would change the appropriateness of POPs for safe and effective continued use based on U.S. MEC (e.g., category 3 and 4 conditions and characteristics).
  • Consider assessing weight changes and counseling women who are concerned about weight changes perceived to be associated with their contraceptive method.

Comments and Evidence Summary. No evidence was found regarding whether a routine follow-up visit after initiating POPs improves correct or continued use.

Missed POPs

For the following recommendations, a dose is considered missed if it has been >3 hours since it should have been taken.

• Take one pill as soon as possible.
• Continue taking pills daily, one each day, at the same time each day, even if it means taking two pills on the same day.
• Use back-up contraception (e.g., condoms) or avoid sexual intercourse until pills have been taken correctly, on time, for 2 consecutive days.
• Emergency contraception should be considered (with the exception of UPA) if the woman has had unprotected sexual intercourse.

Comments and Evidence Summary. Inconsistent or incorrect use of oral contraceptive pills is a major reason for oral contraceptive failure. Unlike COCs, POPs inhibit ovulation in about half of cycles, although this rate varies widely by individual (279). Peak serum steroid levels are reached about 2 hours after administration, followed by rapid distribution and elimination, such that by 24 hours after administration, serum steroid levels are near baseline (279). Therefore, taking POPs at approximately the same time each day is important. An estimated 48 hours of POP use was deemed necessary to achieve the contraceptive effects on cervical mucus (279). Women who frequently miss POPs should consider an alternative contraceptive method that is less dependent on the user to be effective (e.g., IUD, implant, or injectable). No evidence was found regarding the effects of missed POPs available in the United States on measures of contraceptive effectiveness including pregnancy, follicular development, hormone levels, or cervical mucus quality.

Vomiting or Severe Diarrhea (for any Reason or Duration) that Occurs Within 3 Hours After Taking a Pill

• Take another pill as soon as possible (if possible, despite discomfort).
• Continue taking pills daily, one each day, at the same time each day.
• Use back-up contraception (e.g., condoms) or avoid sexual intercourse until 2 days after vomiting or diarrhea has resolved.
• Emergency contraception should be considered (with the exception of UPA) if the woman has had unprotected sexual intercourse.

Comments and Evidence Summary. Theoretically, the contraceptive effectiveness of POPs might be decreased because of vomiting or severe diarrhea. Because of the lack of evidence to address this question, these recommendations are based on the recommendations for missed POPs. No evidence was found regarding the effects of vomiting or diarrhea on measures of contraceptive effectiveness, including pregnancy, follicular development, hormone levels, or cervical mucus quality.