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

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: Vaginal Atrophy
• Intervention / Treatment: Device: VML-0001

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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.	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

• Sponsor: Viramal Limited
• Investigators: Principal Investigator: James Murray, MD, doctor

Study record dates

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: Pathological Conditions, Anatomical; Atrophy
• 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