Exploratory Study on Two Different Doses of VML-0001 on the Effects on Vaginal pH in Healthy Post-Menopausal Women
Sponsor
Viramal Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03770065
Collaborator
(none)
14
1
16.6
0.8
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
14 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date
:
Nov 19, 2018
Actual Primary Completion Date
:
Dec 30, 2019
Actual Study Completion Date
:
Apr 8, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A
|
Device: VML-0001
Medical device
|
| Group B
|
Device: VML-0001
Medical device
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
Female
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Affiliated Research Center, Inc. (MARC) | Huntsville | Alabama | United States | 35801 |
Sponsors and Collaborators
- Viramal Limited
Investigators
- Principal Investigator: James Murray, MD, Doctor
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Viramal Limited
ClinicalTrials.gov Identifier:
NCT03770065
Other Study ID Numbers:
- VML-0001-003
First Posted:
Dec 10, 2018
Last Update Posted:
Oct 6, 2020
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: