Back to resultsVALOR: Vaginal Atrophy & Long-term Observation of Recovery (VALOR)
Primary Purpose
Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
7-0940
Sponsored by
About this trial
This is an interventional treatment trial for Atrophic Vaginitis
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
Sites / Locations
- Orange Coast Women's Medical Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feasibility
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05953090
Brief Title
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Acronym
VALOR
Official Title
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stratpharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrophic Vaginitis, Vaginal Atrophy, Genitourinary Syndrome of Menopause, Lichen Sclerosus of Vulva, Lichen Planus of Vulva, Lichen Simplex of Vulva (Disorder)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Feasibility
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
7-0940
Other Intervention Name(s)
StrataMGT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.
Description
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.
Time Frame
12 months
Title
Change in Vulvar Disease Quality of Life Index (VQLI) score from baseline at 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in investigator-rated severity of visual clinical signs related to the disease, assessed using a 10-point Likert scale
Description
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.
Time Frame
12 months
Title
Change in patient-rated symptom severity assessed using a 10-point Likert scale.
Description
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.
Time Frame
12 months
Title
Change in investigator-rated severity of the overall visual pathology of the disease, assessed using a 10-point Likert scale.
Description
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.
Time Frame
12 months
Title
Adverse Reactions
Description
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.
Time Frame
12 months
Title
Product rating
Description
Product performance is rated by the patient at the final visit after 12 months, using a Likert scale from 1=unsatisfactory to 5=excellent.
Time Frame
12 months
Title
Treatment adherence
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Orange Coast Women's Medical Group
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
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