Trials / Recruiting
RecruitingNCT05953090
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,000 (estimated)
- Sponsor
- Stratpharma AG · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.
Conditions
- Atrophic Vaginitis
- Vaginal Atrophy
- Genitourinary Syndrome of Menopause
- Lichen Sclerosus of Vulva
- Lichen Planus of Vulva
- Lichen Simplex of Vulva (Disorder)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 7-0940 | A non-hormonal and non-steroidal gel that supports vulvovaginal mucosal conditions and speeds up recovery post vaginal rejuvenation. It is a suitable alternative to vaginally administered estrogen and topical corticosteroids, that promotes a moist healing environment leading to faster re-epithelialization. The gel relieves symptoms such as itchiness, tenderness, dryness, burning sensation, painful intercourse (dyspareunia), painful urination (dysuria), rectal and defecating pain. It improves erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids. |
Timeline
- Start date
- 2023-10-30
- Primary completion
- 2028-06-01
- Completion
- 2028-12-01
- First posted
- 2023-07-19
- Last updated
- 2026-02-20
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05953090. Inclusion in this directory is not an endorsement.