Phase 3
Completed N=72
Pericoital Oral Contraception With Levonorgestrel
Healthy
Source: ClinicalTrials.gov NCT00922233 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcomePrimary: Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) — 22.4 pregnancies per 100 woman years
Summary
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35) |
22.4 | — |
| PRIMARY Participant Report of Adverse Events. |
45 | — |
| SECONDARY Acceptability Based on Bleeding Patterns Reported |
43 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00922233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.