Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women

Viramal Limited14 enrolled

Overview

The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vaginal Atrophy

Interventions

VML-0001DEVICE

Medical device

Eligibility

Sex: FEMALEMin age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * be greater than 45 years * no positive findings on screening gynaecological examination * negative smear test within the last 5 years Exclusion Criteria: * has signs of vaginal infection * has evidence of alcohol abuse * has used hormonal replacement therapy in three months prior to study entry

Locations (1)

Medical Affiliated Research Center, Inc. (MARC)

Huntsville, Alabama, United States

Outcomes

Primary Outcomes

To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.

The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.

Time frame: 7-14 days

Data from ClinicalTrials.gov

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