Vaginal Atrophy Clinical Trial
— VALOROfficial title:
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
NCT number | NCT05953090 |
Other study ID # | SPAMG03 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 30, 2023 |
Est. completion date | December 2026 |
Verified date | January 2024 |
Source | Stratpharma AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | December 2026 |
Est. primary completion date | June 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | WR-Charleston Clinical Trials, LLC | Charleston | South Carolina |
United States | WR-Global Medical Research, LLC | Dallas | Texas |
United States | WR-Carolina Institute for Clinical Research | Fayetteville | North Carolina |
United States | Orange Coast Women's Medical Group | Laguna Hills | California |
United States | WR-Multi-Specialty Research Associates | Lake City | Florida |
United States | WR-Clinical Research Center of Nevada, LLC | Las Vegas | Nevada |
United States | WR-PRI, LLC (Los Alamitos) | Los Alamitos | California |
United States | WR-Medical Research Center of Memphis, LLC | Memphis | Tennessee |
United States | WR-PRI, LLC (Newport Beach) | Newport Beach | California |
United States | WR-Women's Health Care Research, LLC | San Diego | California |
United States | WR-Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia |
United States | Southern Urogynecology | West Columbia | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Stratpharma AG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 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. | 12 months | |
Primary | Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 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. | 12 months | |
Secondary | Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale | Signs (dryness, tissue thinning, erosion, fissures, erythema, scarring, contact bleeding, labial fusion, labia reabsorption and contracture of posterior introitus) are rated by the investigator during a physical assessment at baseline and after 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible. | 12 months | |
Secondary | Change in patient-rated symptom severity assessed using a 10-point Likert scale. | Severity of symptoms (itch, burning, pain, irritation, dryness and pain during intercourse) are rated by the patient at baseline and at 12 months, using a 10-point Likert scale ranging from 0=normal to 10=worst possible. | 12 months | |
Secondary | Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale. | Severity of the visual pathology is rated by the investigator during baseline and after 12 months, using a 10-point Likert scale, ranging from 0=normal to 10=worst possible. Overall visual severity may include the severity of pathology at the Clitoral Hood, Urethra Area, Vaginal Vault, Labia Majora / Minora, Fourchette, Perineum, Perianal skin, Extragential site and/or Inguinal folds. | 12 months | |
Secondary | Adverse Reactions | Adverse reactions are rated by the investigator during baseline and after months 3, 6, 9, 12 months, using the dichotomous scale of presence and absence. | 12 months | |
Secondary | Product rating | Product performance is rated by the patient at the final visit after 12 months, using a Likert scale from 1=unsatisfactory to 5=excellent. | 12 months | |
Secondary | Treatment adherence | Treatment adherence is reported by the patient during the final study assessment, indicating the number of days/week and times/day the product was applied during the previous month. Percentage of treatment adherence is calculated from the minimum required treatment schedule. | 12 months |
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