Duration of Effect of Acidform Gel on Vaginal pH

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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).

Key facts

Study ID

NCT02693418

Run by

Evofem Inc.

People needed

105

Starts

2016-08-24

Expected to finish

2016-12-12

Last updated by the study team

2020-11-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Metro Health Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.