Study of Contraceptive Efficacy & Safety of Phexxi™ (Previously Known as Amphora) Gel Compared to Conceptrol Vaginal Gel
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a research study of a new experimental vaginal gel that helps in vaginal pH
      regulation and results in immobilization of spermatozoa by maintaining the normally low
      vaginal pH, even in the presence of semen. This vaginal gel is called Phexxi™ (previously
      known as Amphora) and was compared to a commercially available spermicide called Conceptrol®,
      which contains nonoxynol 9; commonly abbreviated as N-9. Conceptrol® can help prevent
      pregnancy. This study objective was to determine if this product prevents pregnancy when
      inserted into the vagina before intercourse.
    

Detailed description: 
      Clinical Trial Design

      This is a multicenter, open-label, randomized, controlled, Phase III study of repeated use of
      Amphora™ gel compared to Conceptrol® Vaginal Gel as the method of contraception over seven
      cycles of use. In addition, there is an opportunity for Amphora™ gel subjects to continue
      with study treatment for up to 13 cycles of treatment upon completion of the first seven
      cycles of treatment.

      A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will undergo colposcopy at
      the Admission Visit and at the visits after Cycles 1, 3, and 7 (Treatment Exit). Subjects
      participating for 13 cycles will also undergo colposcopy after Cycles 10 and 13. Colposcopic
      photographs will be taken at all visits independent of presence of any suspicious areas. Any
      suspicious areas and clinical findings will be recorded on the colposcopy case report form.
      The colposcopy evaluator for the subset will be blinded regarding the treatment group of the
      subject. If at any time during the study the investigator deems colposcopy necessary,
      colposcopy will be performed on any subject and will not be limited to subjects in the
      colposcopy subset.

      A subset of subjects (Amphora™ gel and Conceptrol® Vaginal Gel) will also have
      semi-quantitative cultures for E. coli and clinical yeast performed at the Admission Visit
      and after Cycles 1, 3, and 7 (Treatment Exit) Visits. Subjects participating for 13 cycles
      will also undergo the assessments after Cycles 10 and 13. Another subgroup will have
      quantitative vaginal cultures performed after Cycles 1 and 7 (Treatment Exit) Visits, and
      also after Cycle 13 for subjects participating in the extension.

      Selected research centers will also recruit subjects into the subset of women 36-45 years of
      age at enrollment.
    

Intervention name(s): Conceptrol; Amphora
Intervention type(s): Drug; Drug
Intervention description(s): • Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.; • Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
Intervention MeSH terms: Nonoxynol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention