Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women
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
1 other identifier
observational
14
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 19, 2018
CompletedFirst Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2020
CompletedOctober 6, 2020
October 1, 2020
1.1 years
December 4, 2018
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group A
Group B
Interventions
Eligibility Criteria
Healthy Post-Menopausal women
You may qualify if:
- be greater than 45 years
- no positive findings on screening gynaecological examination
- negative smear test within the last 5 years
You may not qualify if:
- has signs of vaginal infection
- has evidence of alcohol abuse
- has used hormonal replacement therapy in three months prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viramal Limitedlead
Study Sites (1)
Medical Affiliated Research Center, Inc. (MARC)
Huntsville, Alabama, 35801, United States
Study Officials
- PRINCIPAL INVESTIGATOR
James Murray, MD
Doctor
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 10, 2018
Study Start
November 19, 2018
Primary Completion
December 30, 2019
Study Completion
April 8, 2020
Last Updated
October 6, 2020
Record last verified: 2020-10