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A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom

Phase 3
Completed
Conditions
Contraception
Registration Number
NCT01223313
Lead Sponsor
Health Decisions
Brief Summary

WHAT IS THE FEMALE CONDOM? The female condom being examined in this study is investigational (experimental) and is not yet approved by the Food and Drug Administration (FDA). The female condom is made up of a pouch that adjusts to the shape of the vagina. The female condom that will be used in this study is not lubricated, but a water-based lubricant will be provided for you to use with it. Also, the female condoms used in this study will be provided to you at no cost.

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to find out:

* How well the female condom works to prevent pregnancy

* How well the female condom works to prevent transmission of sexually transmitted diseases

* How safe the female condom is to use

* If urinary tract infections and symptomatic vaginal infections occur while using the female condom

* How well women like the female condom

* How well the female condom performs.

WHAT DOES THE STUDY INVOLVE? There will be approximately 10 clinics in the study with about 500 women from all over the United States participating in this study. You are being asked to participate in a research study because you are a woman between the ages of 18 and 40, are in general good health, have regular menstrual cycles, do not want to become pregnant for at least the next 7 months, and are willing to rely on the female condom as your primary method of contraception during study participation.

HOW LONG DOES THE STUDY LAST? Enrollment for this study is expected to last about 12 months. You will need to come to the clinic for a screening/admission visit and then 2 or more visits. You will also be asked to complete a diary every day about your use of the female condoms. The clinical staff will help set up your planned clinical visits during the study.

Detailed Description

This is a Phase III multicenter, open-label, non-comparative trial of the Woman's Condom to evaluate contraceptive efficacy as the primary method of contraception. Secondary evaluations include safety assessment, incidence of UTIs, symptomatic vaginal infection, performance of the Woman's Condom (clinical breakage, slippage, misdirection, and invagination) and overall acceptability of the product. We will perform a Substudy to assess the semen biomarker as a means of detecting product failure in a subset of subjects.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
500
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Contraceptive EfficacyDetermined at each visit.

The primary objective of the study is to determine the contraceptive efficacy of the Woman's Condom (WC).

Secondary Outcome Measures
NameTimeMethod
Urinary tract infections (UTIs) and symptomatic vaginal infectionAt each visit

Incidence of urinary tract infections (UTIs) and symptomatic vaginal infection.

Chlamydia trachomatis, Neisseria gonorrhea, or trichomoniasis.At each visit

Incidence of acquisition of Chlamydia trachomatis, Neisseria gonorrhea, or trichomoniasis.

Acceptability of the Woman's CondomAt each visit

Acceptability of the Woman's Condom as measured by an acceptability questionnaire administered mid-study (visit 2, after menstrual cycle 3) and at study exit (visit 3, after menstrual cycle 6 or early discontinuation).

Safety of the Woman's CondomAll each visit

Safety of the Woman's Condom using the safety data collected during the clinical trial.

Performance of the Woman's CondomAt each visit

Performance of the Woman's Condom as assessed by self-reported total clinical failure and its components (clinical breakage, slippage, misdirection, and invagination).

Trial Locations

Locations (10)

California Family Health Council, Inc

🇺🇸

Los Angeles, California, United States

Johns Hopkins Bayview Medical Center

🇺🇸

Baltimore, Maryland, United States

NYU Medical Center Family Planning

🇺🇸

New York, New York, United States

Columbia University

🇺🇸

New York, New York, United States

University of Cininnati College of Medicine

🇺🇸

Cincinnati, Ohio, United States

Oregon Health Scieces University

🇺🇸

Portland, Oregon, United States

University of Pennsylvania Medical Center

🇺🇸

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital

🇺🇸

Pittsburgh, Pennsylvania, United States

UT Southwestern Medical Center Dept. of OB/Gyn

🇺🇸

Dallas, Texas, United States

Jones Institute of Reproductive Medicine

🇺🇸

Norfolk, Virginia, United States

California Family Health Council, Inc
🇺🇸Los Angeles, California, United States

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