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

NCT ID: NCT03770065

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-04-08

Brief Summary

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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

Detailed Description

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Conditions

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Vaginal Atrophy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

VML-0001

Intervention Type DEVICE

Medical device

Group B

VML-0001

Intervention Type DEVICE

Medical device

Interventions

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VML-0001

Medical device

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Viramal Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Murray, MD

Role: PRINCIPAL_INVESTIGATOR

Doctor

Locations

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Medical Affiliated Research Center, Inc. (MARC)

Huntsville, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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VML-0001-003

Identifier Type: -

Identifier Source: org_study_id

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