Pericoital Oral Contraception With Levonorgestrel

Inclusion Criteria:

Each woman enrolled in the trial must meet the following inclusion criteria:

• Competent to provide informed consent to participate in the trial and has done so.
• At least the minimum age is 18 to 45 years old.
• Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months.

• At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following:

  • More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months
  • Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C
  • Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma
  • Sharing of illicit injection drug equipment ever in the past.
• Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs).
• Wants to avoid pregnancy for at least the next 6.5 months.
• Willing to accept an uncertain risk of pregnancy during the study.
• Gives correct answers to the informed consent quiz.
• Willing and able to follow all study requirements.

Exclusion Criteria:

To be eligible for enrollment, a woman must not meet any of the following exclusion criteria:

• Pregnant as verified by a pregnancy test at enrollment.

• Has an indication of current subfecundity, specifically:

  • Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy
  • She has not had normal monthly menses for the past 2 months
  • She is currently breastfeeding
  • She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period
  • Has received an injection of a long term injectable contraceptive in the last 9 months
  • Currently has an intrauterine device
  • Has had a sterilization procedure or ectopic pregnancy
  • Has been diagnosed by a clinician as having a fertility problem
  • Her partner has had a sterilization procedure or infertility diagnosis, to her knowledge.

• She currently has known contraindications to progestin-only pills, specifically including the following conditions:

  • Unexplained abnormal vaginal bleeding
  • Deep venous thrombosis or pulmonary embolus
  • Active viral hepatitis
  • Decompensated cirrhosis
  • Liver tumor
  • History of breast cancer within the past 5 years.
• Has a breast mass on examination.
• Has a personal or family history suggestive of predisposition to thrombosis.
• Has a serious contraindication to pregnancy (medical condition or use of chronic medication such as isotretinoin or thalidomide).
• Taking drugs that are known to interact with progestins (such as rifampicin or anticonvulsant medications).
• Has previously participated in this study.
• Currently participating in another medical research study.
• The site investigator or designee perceives another reason to exclude her from the trial.