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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


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).


Minimum age: N/A. Maximum age: 45 Years. Gender(s): Female.


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


- 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


- 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


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

Page last updated: August 23, 2015

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