A Multicenter, Open-Label, Non-Comparative Study of the Safety and Contraceptive Efficacy of the Woman's Condom
Condition: Contraception
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Woman's Condom
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; Woman's Condom; Female Condom; Condom