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NCT05953090 · ClinicalTrials.gov registry record · NA
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
A NA study of Vaginal Atrophy and Genitourinary Syndrome of Menopause, sponsored by Stratpharma.
- Recruiting
- Registry status
- NA
- Development phase
- 2,000
- Enrollment target
- 14
- Study locations
NCT05953090: Recruiting NA study of Vaginal Atrophy and Genitourinary Syndrome of Menopause, sponsored by Stratpharma.
NCT05953090 is a NA study of Vaginal Atrophy and Genitourinary Syndrome of Menopause that is actively recruiting participants, run by Stratpharma. The registered enrollment target is 2,000 participants, above the 134-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (1393% higher). The trial reports 14 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05953090, a NA study of Vaginal Atrophy and Genitourinary Syndrome of Menopause, is actively recruiting participants, sponsored by Stratpharma.
- RECRUITING
- Registry status
- NA
- Development phase
- 2,000 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE 7-0940
Study Locations (14)
California
- 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
South Carolina
- WR-Charleston Clinical Trials, LLC - Charleston
- Southern Urogynecology - West Columbia
Alabama
- Cahaba Dermatology & Skin Health Center - Birmingham
Florida
- WR-Multi-Specialty Research Associates - Lake City
Georgia
- WR-Mount Vernon Clinical Research, LLC - Sandy Springs
Nevada
- WR-Clinical Research Center of Nevada, LLC - Las Vegas
North Carolina
- WR-Carolina Institute for Clinical Research - Fayetteville
Tennessee
- WR-Medical Research Center of Memphis, LLC - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT05953090 shows while recruiting
NCT05953090 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 134-participant average among 9 other Vaginal Atrophy trials with a reported enrollment target (1393% higher).
The record links to 6 conditions, with Vaginal Atrophy appearing as the primary indexed condition, and to 1 intervention - of which 7-0940 is the first listed.
NCT05953090 lists 14 locations in 9 states (California, South Carolina, Alabama).
Frequently Asked Questions
What is clinical trial NCT05953090 about?
NCT05953090 is a clinical study titled "VALOR: Vaginal Atrophy & Long-term Observation of Recovery". 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.
What is the current status of trial NCT05953090?
This trial is currently recruiting. It is a NA study. The enrollment target is 2,000 participants. The study started on 2023-10-30. Estimated completion is 2028-12.
What conditions does trial NCT05953090 study?
This clinical trial studies the following conditions: Vaginal Atrophy, Genitourinary Syndrome of Menopause, Atrophic Vaginitis, Lichen Sclerosus of Vulva, Lichen Planus of Vulva.
What interventions are being tested in trial NCT05953090?
The interventions under investigation include: 7-0940 (DEVICE).
Who is sponsoring clinical trial NCT05953090?
This trial is sponsored by Stratpharma, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05953090 being conducted?
This trial has 14 study locations across Alabama, California, Florida, Georgia, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05953090's enrollment target sits among peer trials
2,000 1st of 9 higher than 9 of 9 other Vaginal Atrophy trials
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