Status:

COMPLETED

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

Lead Sponsor:

Viramal Limited

Conditions:

Vaginal Atrophy

Eligibility:

FEMALE

45+ years

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

Eligibility Criteria

Inclusion

  • be greater than 45 years
  • no positive findings on screening gynaecological examination
  • negative smear test within the last 5 years

Exclusion

  • has signs of vaginal infection
  • has evidence of alcohol abuse
  • has used hormonal replacement therapy in three months prior to study entry

Key Trial Info

Start Date :

November 19 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 8 2020

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT03770065

Start Date

November 19 2018

End Date

April 8 2020

Last Update

October 6 2020

Active Locations (1)

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1

Medical Affiliated Research Center, Inc. (MARC)

Huntsville, Alabama, United States, 35801