NCT04887701

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Madorra · Industry
• Sex: Female
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vulvovaginal Atrophy

Interventions

Type	Name	Description
DEVICE	Non-hormonal vaginal device therapy	Experimental Active Therapy
DEVICE	Sham vaginal device therapy	Sham Comparator

Timeline

• Start date: 2021-07-09
• Primary completion: 2022-08-22
• Completion: 2022-08-22
• First posted: 2021-05-14
• Last updated: 2023-01-13

Locations

3 sites across 1 country: Australia

Regulatory

• FDA-regulated device study