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VALOR: Vaginal Atrophy & Long-term Observation of Recovery
NCT05953090 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05953090
The ClinicalTrials.gov registry entry for NCT05953090 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stratpharma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05953090 reports 14 study locations spanning 9 distinct geographic areas — top geographies include California, South Carolina, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05953090?
The interventions under investigation include: 7-0940 (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05953090?
This trial is sponsored by Stratpharma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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