VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months. — 12 months
  The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvovaginal Symptoms Questionnaire (VSQ) \[min:0; max:16 (for sexually inactive patients) / max: 20 (for sexually active patients)\]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VSQ score at 12 months.
• Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months — 12 months
  The patient-rated quality of life will be assessed at baseline and during each monthly follow-up using the validated patient-rated Vulvar Disease Quality of Life Index (VQLI). \[min:0; max:45\]. A higher score thereby correlates to a worse outcome. The primary endpoint is the change from baseline VQLI score at 12 months.

Trial sites (14)

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