A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
- Conditions
- Contraception
- Interventions
- Device: Woman's Condom
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Woman's Condom Woman's Condom The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC. Women will receive instruction sheets on the use of the WC and lubricant.
- Primary Outcome Measures
Name Time Method Contraceptive Efficacy Determined at each visit. The primary objective of the study is to determine the contraceptive efficacy of the Woman's Condom (WC).
- Secondary Outcome Measures
Name Time Method Urinary tract infections (UTIs) and symptomatic vaginal infection At 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 Condom At 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 Condom All each visit Safety of the Woman's Condom using the safety data collected during the clinical trial.
Performance of the Woman's Condom At 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)
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Jones Institute of Reproductive Medicine
🇺🇸Norfolk, Virginia, United States
Oregon Health Scieces University
🇺🇸Portland, Oregon, United States
UT Southwestern Medical Center Dept. of OB/Gyn
🇺🇸Dallas, Texas, United States
Johns Hopkins Bayview Medical Center
🇺🇸Baltimore, Maryland, United States
NYU Medical Center Family Planning
🇺🇸New York, New York, United States
California Family Health Council, Inc
🇺🇸Los Angeles, California, United States
Columbia University
🇺🇸New York, New York, United States
University of Cininnati College of Medicine
🇺🇸Cincinnati, Ohio, United States
Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States