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Duration of Effect of Acidform Gel on Vaginal pH

NCT02693418 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-11-20

Study results available
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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).

Conditions

  • Healthy

Interventions

DRUG

Acidform 5 g

Effect of 5 g vaginally administered Acidform on pH over 7 days

DRUG

Placebo 4 g

Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days

DRUG

Acidform 4 g

Effect of 4 g vaginally administered Acidform on pH over 7 days

DRUG

Acidform 3 g

Effect of 3 g vaginally administered Acidform on pH over 7 days

Sponsors & Collaborators

  • Clinical Research Management, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    collaborator OTHER

  • MetroHealth Medical Center

    collaborator OTHER

  • Evofem Inc.

    lead INDUSTRY

Principal Investigators

  • Ann Avery, MD · Metro Health Medical Center

  • Seema Nayak, MD · Johns Hopkins University

  • John M Griffiss, MD · Clinical Research Management, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-24
Primary Completion
2016-12-12
Completion
2016-12-12

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02693418 on ClinicalTrials.gov