VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Conditions

• Atrophic Vaginitis
• Genitourinary Syndrome of Menopause
• Lichen Planus of Vulva
• Lichen Sclerosus of Vulva
• Lichen Simplex of Vulva (Disorder)
• Vaginal Atrophy

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 7-0940 — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Oct 30, 2023

Status verified

Feb 2026

Primary completion

Jun 30, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

2,000 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Feasibility

Primary Outcome Measure

Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months. [ Time Frame: 12 months ]

Locations (14)

Find similar trials in Birmingham, AL

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