A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and
acceptability of pericoital oral contraception with levonorgestrel
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Locations near you
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Full eligibility criteria for NCT00922233
Ages eligible for Study
up to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
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.
All locations for NCT00922233
United States (3)
Planned Parenthood of the Rocky Mountains
Denver, Colorado, United States, 80232
Planned Parenthood Gulf Coast, Inc.
Houston, Texas, United States, 77004
Planned Parenthood Association of Utah
Salt Lake City, Utah, United States, 84102
Trial results for NCT00922233
Participant Flow: Overall Study
68 / 72
Completed / Started
Serious Adverse Events
0 / 72
Affected / At Risk
Other Adverse Events
28 / 72
Affected / At Risk
View full eligibility
Tris trial is registered with FDA with number: NCT00922233. The sponsor of the trial is FHI 360 and it is looking for 72 volunteers for the current phase.
Official trial title: Pericoital Oral Contraception With Levonorgestrel: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Acceptability
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