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NCT03770065 Clinical Trial

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

Vaginal Atrophy Clinical Trial

Official title:
A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03770065
Other study ID # VML-0001-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 19, 2018
Est. completion date April 8, 2020

Study information
Verified date October 2020
Source Viramal Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date April 8, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 45 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• VML-0001
Medical device

Locations
Country Name City State
United States Medical Affiliated Research Center, Inc. (MARC) Huntsville Alabama

Sponsors (1)
Lead Sponsor Collaborator
Viramal Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 7-14 days
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