VALOR: Vaginal Atrophy & Long-term Observation of Recovery

What this trial studies

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 in scope

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

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…

Who can join

Women only · Ages 18 Years and up

Inclusion criteria

• Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus
• Continuous vulvovaginal symptoms
• Access to smartphone and tablet, laptop or computer
• Access to a valid email address

Exclusion criteria

• Unable to provide informed consent
• Patient unable to apply topical device
• Allergy or intolerance to ingredients or excipients of the formulation of studied products
• Systemic hormonal therapy started less than 30 days before baseline
• Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline
• Ongoing topical HRT or corticosteroid treatment for the indication under investigation
• Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Showing the first 10 of 14 sites. See all sites on ClinicalTrials.gov.

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2023-10-30
• Primary completion: 2028-06
• Last update posted: 2026-02-20
• First posted: 2023-07-19

Sponsor & contact

Lead sponsor: Stratpharma AG (Industry)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.