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

NCT04887701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-01-13

No results posted yet for this study

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.

Conditions

  • Vulvovaginal Atrophy

Interventions

DEVICE

Non-hormonal vaginal device therapy

Experimental Active Therapy

DEVICE

Sham vaginal device therapy

Sham Comparator

Sponsors & Collaborators

  • Madorra

    lead INDUSTRY

Principal Investigators

  • Rodney Baber, MD · North Shore Private Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2022-08-22
Completion
2022-08-22
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04887701 on ClinicalTrials.gov