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

Viramal

Status: Completed

Conditions: Vaginal Atrophy

Treatments: Device: VML-0001

Study type: Observational

Funder types: Industry

Identifiers

NCT03770065

VML-0001-003

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 2 patient groups

Group A

Treatment:

Device: VML-0001

Group B

Treatment:

Device: VML-0001