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VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Stratpharma AG · NCT05953090

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
2000
US sites recruiting
6
Study start
October 30, 2023
Record last updated
February 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: 7-0940

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Cahaba Dermatology & Skin Health Center

    Birmingham, AL 35244

    Site contact: Jennifer Perry · 205 778-1564 · jperry@cahabaderm.com

  • Velvet Clinical Research

    Burbank, CA 91506

    Site contact: Monica Torres · 323-527-0907 · mtorres@velvetclinicalresearch.com

  • WR-PRI, LLC (Newport Beach)

    Newport Beach, CA 92660

    Site contact: Diana Nguyen · (949) 752-7910 · dnguyen@wakeresearch.com

  • WR-Carolina Institute for Clinical Research

    Fayetteville, NC 28303

    Site contact: Caitlyn Miller · (910) 302-8151 · cmiller@wakeresearch.com

  • Southern Urogynecology

    West Columbia, SC 29169

    Site contact: Tina McGready · 803-457-7000 · tmcgready@southurogyn.com

  • WR-Global Medical Research, LLC

    Dallas, TX 75224

    Site contact: Vicki Martinez · (469) 297-3074 · vmartinez@wakeresearch.com

VALOR: Vaginal Atrophy & Long-term Observation of Recovery (NCT05953090) | Bored Studies