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

October 5, 2020 updated by: Viramal Limited

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc. (MARC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy Post-Menopausal women

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A
Device: VML-0001
Medical device
Group B
Device: VML-0001
Medical device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viramal Limited

Investigators

  • Principal Investigator: James Murray, MD, doctor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2018

Primary Completion (ACTUAL)

December 30, 2019

Study Completion (ACTUAL)

April 8, 2020

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (ACTUAL)

December 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VML-0001-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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