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Non-hormonal Medical Device for Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women

Vulvovaginal Atrophy Clinical Trial

Official title:
Clinical Outcomes and Safety of a Non-hormonal Medical Device Versus a Sham Device on the Treatment of Vulvovaginal Atrophy (VVA) in Post-Menopausal Women Who Have Failed, Refused, or Are Contraindicated for Hormone Therapy

Clinical Trial Summary

Randomized (1:1), double-blind, sham-controlled, 2-arm parallel study comparing effectiveness and safety of non-hormonal medical device versus sham device to treat VVA in post-menopausal women.

Clinical Trial Description

After screening and baseline assessment, participants, ages 21 to 65 years of age, will be randomized and followed for a 12-week intervention period. After the primary endpoint evaluation at week 12, each participant in both arms will immediately commence an open label period using an Active device for week 13 to 1 year to collect further effectiveness and safety data. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04887701
Study type Interventional
Source Madorra
Contact
Status Completed
Phase N/A
Start date July 9, 2021
Completion date August 22, 2022
View Details
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