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OpenTrials
Completed

NCT Number: NCT03770065

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

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

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Key information

Conditions

Vaginal Atrophy

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medical Affiliated Research Center, Inc. (MARC)

Huntsville, Alabama, 35801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VML-0001

Device

Medical device

Primary outcomes

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

    Time frame: 7-14 days

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

Sponsors and collaborators

Lead sponsor

Viramal Limited

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 10, 2018
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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