Pericoital Oral Contraception With Levonorgestrel
Information source: FHI 360
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: levonorgestrel (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: FHI 360 Official(s) and/or principal investigator(s): Vera Halpern, MD, Principal Investigator, Affiliation: FHI 360
Summary
A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and
acceptability of pericoital oral contraception with levonorgestrel
Clinical Details
Official title: Pericoital Oral Contraception With Levonorgestrel: A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate Efficacy, Safety and Acceptability
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)Participant Report of Adverse Events.
Secondary outcome: Acceptability Based on Bleeding Patterns Reported
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 as stated in the study protocol are as follows:
- To evaluate the efficacy of the study regimen among women who have sex 1-4 days a month
and who are relying on the study regimen as their primary method of contraception
- To evaluate the safety of this regimen, with particular emphasis on its effects on
vaginal bleeding patterns and anemia
- To evaluate the acceptability of the regimen The study will enroll fertile women of
reproductive age who have sex up to 6 days a month, are at low risk for sexually
transmitted infections (STIs), have no contraindications to progestin-only oral
contraceptives,have no serious contraindications to pregnancy, and are willing to use
an investigational method of contraception as their only contraceptive method for 6. 5
months (each tablet contains 0. 75 mg LNG to be used after every sex act).
Eligibility
Minimum age: N/A.
Maximum age: 45 Years.
Gender(s): Female.
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.
Locations and Contacts
CEMICAMP, Campinas, Brazil
Planned Parenthood of the Rocky Mountains, Denver, Colorado 80232, United States
Planned Parenthood Gulf Coast, Inc., Houston, Texas 77004, United States
Planned Parenthood Association of Utah, Salt Lake City, Utah 84102, United States
Additional Information
Starting date: January 2010
Last updated: August 22, 2013
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