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

Completed

• Conditions: Vaginal Atrophy
• Interventions: Device: VML-0001

• Registration Number: NCT03770065
• Lead Sponsor: Viramal Limited

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-19
• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Primary Completion: 2019-12-30
• Study Completion: 2020-04-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	VML-0001	-
Group A	VML-0001	-

Primary Outcome Measures

Name	Time	Method
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.	7-14 days	The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.

Trial Locations

Locations (1)

Medical Affiliated Research Center, Inc. (MARC); 🇺🇸 Huntsville, Alabama, United States