Trials / Completed
CompletedNCT04766957
Pilot Clinical Trial of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
Pilot Clinical Trial on the Efficacy and Safety of IDRACARE® in Moderate to Severe Symptoms of Vulvovaginal Atrophy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 134 (actual)
- Sponsor
- Procare Health Iberia S.L. · Industry
- Sex
- Female
- Age
- 40 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause.
Detailed description
Pilot clinical trial on the efficacy and safety of IDRACARE® in moderate to severe symptoms of vulvovaginal atrophy. To assess the efficacy and safety of Idracare® in the treatment of symptoms of AVV (dryness and / or dyspareunia) associated with menopause. Open study with only one arm. The study has a total duration per patient of 3 months: initial visit (V1), a follow-up visit (V2) after 4 weeks of treatment and a final visit (V3) after 12 weeks of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Idracare | Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed. |
Timeline
- Start date
- 2020-10-26
- Primary completion
- 2021-12-31
- Completion
- 2022-12-02
- First posted
- 2021-02-23
- Last updated
- 2023-01-27
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04766957. Inclusion in this directory is not an endorsement.