Trials / Unknown
UnknownNCT03823560
Performance and Safety of Class IIb MD Celegyn® in VVA
Evaluation of Performance and Safety of the CE Marked Medical Device Class IIb Celegyn® in Vulvovaginal Atrophy (VVA): a Randomised, Double-blind, Parallel Groups, Multicentric, Placebo-Controlled, Prospective Clinical Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 96 (estimated)
- Sponsor
- Nathura S.p.A · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is primarily to investigate the performance of Celegyn®, a hyaluronic acid-based vaginal cream (CE marked 0546 medical device), enriched with plant-based ingredients, in comparison with placebo, in promoting vaginal health in adult woman reporting symptoms of vulvovaginal atrophy - VVA (or atrophic vulvovaginitis)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Celegyn® | Medical device Celegyn® presents itself as a cream. |
| DEVICE | Matching placebo | IP placebo presents itself as a cream. |
Timeline
- Start date
- 2019-09-24
- Primary completion
- 2021-09-01
- Completion
- 2021-09-01
- First posted
- 2019-01-30
- Last updated
- 2021-01-06
Locations
3 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03823560. Inclusion in this directory is not an endorsement.