Vaginal Dryness Clinical Trial
Official title:
Efficacy, Tolerability and Safety of a New Medical Device, Zp-025 Vaginal Gel, in the Treatment of Vaginal Dryness in Post-menopausal Women With Vaginal Atrophy
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.
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
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