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Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness
This study evaluates the efficacy and safety of a new hyaluronic acid-based vaginal moisturizer gel to ease symptoms of vaginal dryness compared to a commonly used marketed vaginal moisturizer (Cumluade Hidratante Interno®).
This is a prospective, multicenter, randomized, controlled, double-blind clinical investigation to evaluate the safety and efficacy of a new hyaluronic acid-based vaginal moisturizer gel (medical device class IIb) in women with symptoms of vaginal atrophy and dryness, compared to a commonly used marketed vaginal moisturizer in gynecology clinics (Cumluade Hidratante Interno®), with a 1-month follow-up. The participants will apply the single dose of vaginal moisturizer 3 times per week, every other day, preferably in the evening. The investigators will monitor the evolution of vaginal symptoms, vaginal health using the Vaginal Health Index (VHI), sexual function using the Female Sexual Function Index (FSFI) questionnaire, and the safety and tolerability of the new class IIb medical device.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Corofas Menopause
Tomelloso, Ciudad Real, Spain
Start Date
May 23, 2023
Primary Completion Date
October 18, 2023
Completion Date
October 18, 2023
Last Updated
February 20, 2024
54
ACTUAL participants
Hidrante HA
DEVICE
Cumlaude Hidrante Interno®
DEVICE
Lead Sponsor
Dermofarm, S.A.U
NCT06470906
NCT06519799
Data Source & Attribution
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