Pericoital Oral Contraception With Levonorgestrel

Completed · Phase 3

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT00922233

Run by

FHI 360

People needed

72

Starts

2010-01-01

Expected to finish

2010-11-01

Last updated by the study team

2013-10-29

Who can join

Age: any, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Planned Parenthood of the Rocky Mountains — Denver, Colorado, United States
• Planned Parenthood Gulf Coast, Inc. — Houston, Texas, United States
• Planned Parenthood Association of Utah — Salt Lake City, Utah, United States
• CEMICAMP — Campinas, Campinas, Brazil

Full record on ClinicalTrials.gov

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