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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03770065

Enrollment

Registered

2018-12-10

Start date

2018-11-19

Completion date

2020-04-08

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Atrophy

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

Interventions

DEVICEVML-0001

Medical device

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.	7-14 days	The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026