Pericoital Oral Contraception With Levonorgestrel
Condition: Healthy
Intervention: levonorgestrel
Intervention description: oral contraceptive pills
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: Female
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception

Summary:

      A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and
      acceptability of pericoital oral contraception with levonorgestrel
    

Eligibility criteria:

        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.