RECRUITING

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Quick Facts

Study Start:2023-10-30
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05953090

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus
  2. * Continuous vulvovaginal symptoms
  3. * Access to smartphone and tablet, laptop or computer
  4. * Access to a valid email address
  1. * Unable to provide informed consent
  2. * Patient unable to apply topical device
  3. * Allergy or intolerance to ingredients or excipients of the formulation of studied products
  4. * Systemic hormonal therapy started less than 30 days before baseline
  5. * Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline
  6. * Ongoing topical HRT or corticosteroid treatment for the indication under investigation
  7. * Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline

Contacts and Locations

Study Locations (Sites)

Orange Coast Women's Medical Group
Laguna Hills, California, 92653
United States
WR-PRI, LLC (Los Alamitos)
Los Alamitos, California, 90720
United States
WR-PRI, LLC (Newport Beach)
Newport Beach, California, 92660
United States
WR-Women's Health Care Research, LLC
San Diego, California, 92111
United States
WR-Multi-Specialty Research Associates
Lake City, Florida, 32055
United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328
United States
WR-Clinical Research Center of Nevada, LLC
Las Vegas, Nevada, 89106
United States
WR-Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303
United States
WR-Charleston Clinical Trials, LLC
Charleston, South Carolina, 29414
United States
Southern Urogynecology
West Columbia, South Carolina, 29169
United States
WR-Medical Research Center of Memphis, LLC
Memphis, Tennessee, 38210
United States
WR-Global Medical Research, LLC
Dallas, Texas, 75224
United States

Collaborators and Investigators

Sponsor: Stratpharma AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-30
Study Completion Date2026-12

Study Record Updates

Study Start Date2023-10-30
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

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