VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Last updated: January 31, 2024
Sponsor: Stratpharma AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Warts

Vaginal Atrophy

Vaginitis

Treatment

7-0940

Clinical Study ID

NCT05953090
SPAMG03
  • Ages > 18
  • Female

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: 7-0940
Phase:
Study Start date:
October 30, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Orange Coast Women's Medical Group

    Laguna Hills, California 92653
    United States

    Site Not Available

  • WR-PRI, LLC (Los Alamitos)

    Los Alamitos, California 90720
    United States

    Site Not Available

  • WR-PRI, LLC (Newport Beach)

    Newport Beach, California 92660
    United States

    Active - Recruiting

  • WR-Women's Health Care Research, LLC

    San Diego, California 92111
    United States

    Site Not Available

  • WR-Multi-Specialty Research Associates

    Lake City, Florida 32055
    United States

    Site Not Available

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • WR-Clinical Research Center of Nevada, LLC

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • WR-Carolina Institute for Clinical Research

    Fayetteville, North Carolina 28303
    United States

    Active - Recruiting

  • WR-Charleston Clinical Trials, LLC

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Southern Urogynecology

    West Columbia, South Carolina 29169
    United States

    Active - Recruiting

  • WR-Medical Research Center of Memphis, LLC

    Memphis, Tennessee 38210
    United States

    Site Not Available

  • WR-Global Medical Research, LLC

    Dallas, Texas 75224
    United States

    Active - Recruiting

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