Efficacy and Tolerability Study of ZP-025 Vaginal Gel for the Treatment of Vaginal Dryness

Zambon

Status

Completed

Conditions

Vaginal Dryness

Treatments

Device: Vaginal gel, Medical Device Class 2A

Study type

Interventional

Funder types

Industry

Identifiers

NCT02994342

Z7213M02

Details and patient eligibility

About

Evaluation of ZP-025 vaginal gel in terms of efficacy and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy after 56 consecutive days and at 4-week follow-up only for women applying ZP-025 vaginal gel.

Full description

Evaluation of ZP-025 vaginal gel in terms of efficacy, tolerability and safety in the treatment of vaginal dryness in post-menopausal women with vaginal atrophy in comparison to a group of non-treated post-menopausal women with vaginal atrophy for 56 consecutive days.

This trial will be conducted in compliance with last version of Declaration of Helsinki, with GCP as applicable to investigations with IMD, with the applicable regulatory requirements and with CRO and Sponsor's SOPs.

This is a multi-centre, national, randomized, controlled vs. no-treatment, open label study The study will take place in 6 centers of menopause at public Hospitals/Universities. An ancillary study will be carried on for subjects randomized to ZP-025 group with a follow-up visit at 4 weeks

Enrollment

121 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

caucasian women <70 years, in physiological postmenopausal status for at least 2 years;
women with signs and symptoms of vaginal atrophy (i. e. vaginal discomfort, itching, dyspareunia, dryness);
signed informed consent; willing and able to comply with study procedures

Exclusion criteria

childbearing potential women;
ascertained or presumptive hypersensitivity to the formulation ingredients;
therapy with systemic or vaginal oestrogens within 6 months from the inclusion;
current urinary or vaginal infection (cultural positive result to vaginal or urines microbiological swab in the 7 days preceding inclusion);
previous episodes of vaginal bleeding or spotting in the last 6 months;
vaginal prolapse and any other disease that could interfere with the study conduction and participation