A Safety Study Of The Caya® Diaphragm Used With ContraGel®
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of ContraGel versus the
      hydroxyethylcellulose (HEC) Universal Placebo gel when used with the Caya diaphragm during
      two 7-day periods of daily use, the first without intercourse and the second with
      intercourse.
    

Detailed description: 
      This single-center randomized, parallel, Phase I study will compare the safety of ContraGel
      delivered by the Caya diaphragm versus HEC universal placebo gel delivered by the Caya
      diaphragm in approximately 24 healthy premenopausal women protected from pregnancy by female
      sterilization. Women will use the assigned product during two 7-day periods of daily use, the
      first without intercourse and the second with intercourse.

      Each woman will be seen in approximately 6 visits and will be contacted via one scheduled
      follow-up call after Visit 6.

      At Visit 1, volunteers will be consented and undergo procedures to confirm they are eligible
      to continue in the study.

      At Visit 2, once it has been confirmed that the participant meets all of the inclusion
      criteria and none of the exclusion criteria, baseline genital tract samples will be taken.

      At Visit 3,baseline genital tract samples will be taken for Test Cycle 1 (before product use
      with no intercourse). Participants will be randomized in a 1:1 ratio to insert the Caya
      diaphragm to deliver either ContraGel or the HEC placebo every day for two 7-day periods in
      two separate menstrual cycles. The participant will receive study supplies. She will be
      instructed to refrain from intercourse during the first 7-day period and to insert the Caya
      each day for between 6-12 hours. She will be instructed to return to the clinic at Visit 4
      with the diaphragm in place.

      At Visit 4, genital tract samples will be taken after 7 days of product use without
      intercourse (Test Cycle 1).

      At Visit 5, baseline genital tract samples will be taken for Test Cycle 2 (before product use
      with intercourse). The participant will receive study supplies and will be instructed to
      engage in two sex acts during this 7-day period, the second sex act to take place using the
      study products 6-12 hours prior to Visit 6. Participants will be instructed to return to the
      clinic at Visit 6 with the diaphragm still in place.

      At Visit 6, genital tract samples will be taken after 7 days of product use with intercourse
      (Test Cycle 2).

      A follow-up call/contact will be scheduled for 1 to 2 weeks after Visit 6. The participant
      will be asked about any adverse events (AEs) experienced and medications taken since the last
      visit. The participant will then be exited from the study, unless she has symptoms that
      require follow-up.
    

Intervention name(s): ContraGel; HEC Universal Placebo gel
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Contraception; Vaginal Gel; Diaphragm