VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Vaginal Atrophy Clinical Trial

— VALOR  

Official title:

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953090
• Other study ID #: SPAMG03
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Stratpharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Genitourinary Syndrome of Menopause
• Lichen Planus
• Lichen Planus of Vulva
• Lichen Sclerosus et Atrophicus
• Lichen Sclerosus of Vulva
• Vaginal Atrophy
• Vaginitis
• Vulvar Lichen Sclerosus

Intervention

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 erythema, mucosal tissue thinning, erosions, fissures, ulcerations, scarring/adhesions and swelling. It is indicated for long-term use to maintain the health of the vaginal mucosa without the side effects of vaginally administered hormonal therapy and topical corticosteroids.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stratpharma AG

Country where clinical trial is conducted

United States, 

Outcome

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