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Recruiting NCT05953090

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

No phase Interventional Atrophic Vaginitis Vaginal Atrophy Genitourinary Syndrome of Menopause Lichen Sclerosus of Vulva

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 7-0940.
Who it may be relevant to
Registry conditions: Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device 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 ery

Primary outcome measures

  • Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months. [Time frame: 12 months]
  • Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months [Time frame: 12 months]
Secondary outcome measures (6)
  • Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale [Time frame: 12 months]
  • Change in patient-rated symptom severity assessed using a 10-point Likert scale. [Time frame: 12 months]
  • Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale. [Time frame: 12 months]
  • Adverse Reactions [Time frame: 12 months]
  • Product rating [Time frame: 12 months]
  • Treatment adherence [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 14 centers
  • Cahaba Dermatology & Skin Health Center — Birmingham
  • Velvet Clinical Research — Burbank
  • Orange Coast Women's Medical Group — Laguna Hills
  • WR-PRI, LLC (Los Alamitos) — Los Alamitos
  • WR-PRI, LLC (Newport Beach) — Newport Beach
  • WR-Women's Health Care Research, LLC — San Diego
  • WR-Multi-Specialty Research Associates — Lake City
  • WR-Mount Vernon Clinical Research, LLC — Sandy Springs
  • … and 6 more centers

Identifiers

NCT: NCT05953090 · SPAMG03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗