Status:
COMPLETED
Pericoital Oral Contraception With Levonorgestrel
Lead Sponsor:
FHI 360
Conditions:
Healthy
Eligibility:
FEMALE
Up to 45 years
Phase:
PHASE3
Brief Summary
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel
Detailed Description
This is a prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel (LNG). The objectives of the study ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00922233
Start Date
January 1 2010
End Date
November 1 2010
Last Update
October 29 2013
Active Locations (4)
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1
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States, 80232
2
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, United States, 77004
3
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102
4
CEMICAMP
Campinas, Campinas, Brazil