Duration of Effect of Acidform Gel on Vaginal pH
Condition: Healthy
Intervention: Acidform 5 g; Placebo 4 g; Acidform 4 g; Acidform 3 g
Intervention description: 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
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 105.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy female subjects between 18 and 45 years, inclusive

          2. Ability to understand the consent process and procedures

          3. Subjects agree to be available for all study visits

          4. Written informed consent in accordance with institutional guidelines

          5. Negative pregnancy test

          6. Able and willing to comply with all study procedures

          7. Have not engaged in sexual intercourse, douching or used of any form of vaginal
             suppository or intravaginal device for 24 hours prior to enrollment.

          8. Agree to abstain from sexual intercourse, douching or any form of vaginal suppository
             or intravaginal device use during course of study

          9. Report menstrual cycle regularity (25- to 35- day menstrual cycles)

        Exclusion Criteria:

          1. Participation in any study with an investigational compound or device within 30 days
             prior to signing informed consent

          2. Active drug or alcohol use or dependence that, in the opinion of the investigator,
             would interfere with adherence to study protocol

          3. Any other medical condition(s) that, in the judgment of the investigator, might
             interfere with the study or require treatment that might interfere with the study

          4. Family member of the investigation study staff

          5. Pregnant or breast-feeding

          6. Inability to provide informed consent

          7. A subject with a history or expectation of noncompliance with medications or treatment
             protocol

          8. Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection
             (STI) reported or observed during examination, at screening*.

          9. Women who regularly use douches, vaginal medications or suppositories, feminine
             sprays, genital wipes or contraceptive spermicides, or report abnormal vaginal
             discharge in the past 48 hours prior to screening

         10. Women who are menstruating or who would expect to menstruate during the study

         11. Women who are currently using contraceptives that are directly delivered to the
             vaginal mucosa, such as NuvaRing

         12. Any specific condition that, in the judgment of the Investigator, precludes
             participation because it could affect subject safety