NCT05953090 VALOR: Vaginal Atrophy & Long-term Observation of Recovery
| NCT ID | NCT05953090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stratpharma AG |
| Condition | Atrophic Vaginitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,000 participants in total. It began in 2023-10-30 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Frequently Asked Questions
Who can join the NCT05953090 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Atrophic Vaginitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05953090 currently recruiting?
Yes, NCT05953090 is actively recruiting participants. Visit ClinicalTrials.gov or contact Stratpharma AG to inquire about joining.
Where is the NCT05953090 trial being conducted?
This trial is being conducted at Birmingham, United States, Burbank, United States, Laguna Hills, United States, Los Alamitos, United States and 10 additional locations.
Who is sponsoring the NCT05953090 clinical trial?
NCT05953090 is sponsored by Stratpharma AG. The trial plans to enroll 2,000 participants.