Pericoital Oral Contraception With Levonorgestrel

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Treatments: Levonorgestrel

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.