Phase 1
N=105
Duration of Effect of Acidform Gel on Vaginal pH
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02693418 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. — 4.85; 4.81; 4.91; 5.00 pH
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Acidform 5 g (Drug); Placebo 4 g (Drug); Acidform 4 g (Drug); Acidform 3 g (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Evofem Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vaginal pH Following a Single Dose of Acidform (3, 4, and 5 g), HEC Placebo (4 g), or no Intervention. |
4.85; 4.81; 4.91; 5.00; 4.77; -0.44 | — |
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
- Healthy female subjects between 18 and 45 years, inclusive
- Ability to understand the consent process and procedures
- Subjects agree to be available for all study visits
- Written informed consent in accordance with institutional guidelines
- Negative pregnancy test
- Able and willing to comply with all study procedures
- Have not engaged in sexual intercourse, douching or used of any form of vaginal suppository or intravaginal device for 24 hours prior to enrollment.
- Agree to abstain from sexual intercourse, douching or any form of vaginal suppository or intravaginal device use during course of study
- Report menstrual cycle regularity (25- to 35- day menstrual cycles)
Exclusion Criteria
- Participation in any study with an investigational compound or device within 30 days prior to signing informed consent
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study protocol
- 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
- Family member of the investigation study staff
- Pregnant or breast-feeding
- Inability to provide informed consent
- A subject with a history or expectation of noncompliance with medications or treatment protocol
- Women with symptoms of Urinary Tract Infection (UTI) or Sexually Transmitted Infection (STI) reported or observed during examination, at screening*.
- 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
- Women who are menstruating or who would expect to menstruate during the study
- Women who are currently using contraceptives that are directly delivered to the vaginal mucosa, such as NuvaRing
- Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety
Data sourced from ClinicalTrials.gov (NCT02693418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.