Duration of Effect of Acidform Gel on Vaginal pH
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to determine the magnitude and duration of the reduction in
      pH (acidification) following a single dose of Acidform vaginal gel containing 3, 4, or 5 g
      compared with hydroxyethylcellulose placebo gel (4 g) or no treatment. Vaginal pH was
      measured 1 h, 6 h, 12 h, 24 h, then once daily for 7 days. In addition, the participants were
      assessed for an exploratory endpoint to the determine effect of one dose of Acidform gel (3,
      4 or 5 g) or placebo gel (4 g) or no treatment, on asymptomatic bacterial vaginosis (BV).
    

Detailed description: 
      One hundred healthy volunteer women, 20 per each treatment arm, were treated with either
      Intravaginal Acidform Gel(IVAG), 5 g dose (GROUP A), Acidform gel, 4 g dose (GROUP B),
      Acidform gel, 3 g dose (GROUP C), Universal Placebo Gel (UPG), 4 g (GROUP D) or no treatment
      (GROUP E). For GROUPS A, B, C and D, treatment is defined as speculum exam plus instillation
      of Investigational Product (IP) or placebo gel. For GROUP E (control), no treatment is
      defined as speculum exam and no gel instillation.

      At least 15 women in each group were of either African American or Hispanic ethnicity.
      Routine screening tests were performed on admission; and subjects assessed for BV via vaginal
      swabs obtained for grading by Amsel criteria.

      A direct vaginal pH reading by research staff- was obtained before the speculum exam, as well
      as one hour, and six hours post-treatment (Day 0). At the one hour and six hour post
      treatment time points, the direct vaginal pH readings were taken on specimens collected from
      two different positions in the vagina, in case of incomplete distribution of the IP soon
      after administration. Both readings are included as data points. At the six hour timepoint,
      subjects were trained on self-collecting vaginal swabs and performing the vaginal pH test. At
      12 hours post-treatment, subjects performed the vaginal pH test themselves using
      self-obtained swabs, and record their results for clinician review.

      Subjects stayed overnight in the domiciliary unit, and vaginal pH and Amsel criteria was
      measured again by research staff at 24 (+/- 2) hours post-treatment before discharge on Day
      1. The subjects were discharged with the appropriate pH testing supplies and diary. All women
      agreed to abstain from sexual intercourse, douching and use of any intravaginally applied
      products or devices until after their final study visit on Day 7.

      Subjects measured their vaginal pH at 24 (+/-2) hour intervals for 5 days (Days 2-6) as
      outpatients and recorded the pH test results, and any change in vaginal comfort, in a
      provided diary. Subjects also recorded any activities engaged in from the abstinence criteria
      in the study exclusion list, if applicable, each day. On Day 7, subjects returned to the
      clinic with their diaries, had their vaginal pH and Amsel criteria determined by the clinic
      staff, and queried as to any vaginal discomfort (vaginal comfort assessment) over the course
      of the study, as self-recorded in their diaries.
    

Intervention name(s): Acidform 5 g; Placebo 4 g; Acidform 4 g; Acidform 3 g
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Effect of 5 g vaginally administered Acidform on pH over 7 days; Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days; Effect of 4 g vaginally administered Acidform on pH over 7 days; Effect of 3 g vaginally administered Acidform on pH over 7 days
Other intervention name(s): Natrasol 250 HX Pharm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention