NCT05888116

Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

Clinical Investigation to Evaluate the Efficacy and Safety of a Hyaluronic Acid-Based Vaginal Moisturizer Medical Device to Ease Symptoms of Vaginal Dryness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dermofarm, S.A.U · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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®).

Detailed description

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.

Conditions

• Vaginal Disease

Interventions

Type	Name	Description
DEVICE	Hidrante HA	Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.
DEVICE	Cumlaude Hidrante Interno®	Apply the 5 ml single dose three times a week, every other day, preferably at night before going to bed for 4 weeks.

Timeline

• Start date: 2023-05-23
• Primary completion: 2023-10-18
• Completion: 2023-10-18
• First posted: 2023-06-05
• Last updated: 2024-02-20

Locations

1 site across 1 country: Spain