Pericoital Oral Contraception With Levonorgestrel

NCT00922233 | Completed Phase 3 Results

• 1 other identifier: 10139
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 4

Brief Summary

A prospective, open-label, single arm, multicenter study to evaluate efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel

Conditions

Healthy

Keywords

Contraception

Outcome Measures

Primary Outcomes (2)

• Efficacy: the Pearl Index (Number of Pregnancies Per 100 Woman-years) in the Primary Evaluable Population (18-35)

  Participants were followed for 6.5 months.Pearl Index in the 18-35 year population was collected excluding months in which barrier methods, condoms, or emergency contraception were used unless the subject conceived

  6.5 months

• Participant Report of Adverse Events.

  Safety data includes data from each subject up to two weeks after her last use of the study tablets as well as all events deemed related to study product, regardless of date last tablet was taken

  6.5 months

Secondary Outcomes (1)

• Acceptability Based on Bleeding Patterns Reported

  6.5 months

Study Arms (1)

Levonorgestrel

EXPERIMENTAL

0.75 mg of levonorgestrel within 24 hours of sex

Drug: levonorgestrel

Interventions

levonorgestrel DRUG

oral contraceptive pills

Levonorgestrel

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• FHI 360: lead

Study Sites (4)

Planned Parenthood of the Rocky Mountains

Denver, Colorado, 80232, United States

Location

Planned Parenthood Gulf Coast, Inc.

Houston, Texas, 77004, United States

Location

Planned Parenthood Association of Utah

Salt Lake City, Utah, 84102, United States

Location

CEMICAMP

Campinas, Campinas, Brazil

Location

Related Publications (1)

• Taylor DJ, Lendvay A, Halpern V, Bahamondes LG, Fine PM, Ginde SY, Wheeless A, Raymond EG. A single-arm study to evaluate the efficacy, safety and acceptability of pericoital oral contraception with levonorgestrel. Contraception. 2014 Mar;89(3):215-21. doi: 10.1016/j.contraception.2013.11.013. Epub 2013 Nov 26.

  PMID: 24388695 DERIVED

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Vera Halpern
• Organization: FHI360

vhalpern@fhi360.org

9195447040

Study Officials

• Vera Halpern, MD

  FHI 360

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 17, 2009
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 29, 2013
• Results First Posted: October 29, 2013

Record last verified: 2013-08

Locations

BR (1); US (3)