VALOR: Vaginal Atrophy & Long-term Observation of Recovery
This study, called VALOR, is testing a non-hormonal and non-steroidal gel called 7-0940. This gel is designed to help with vulvovaginal (outer female genital and vaginal) conditions like atrophic vaginitis (vaginal dryness and irritation), lichen sclerosus, and lichen planus. Researchers want to see how safe and effective 7-0940 is over time. You might be able to join if you are an adult woman diagnosed with one of these conditions, have ongoing symptoms, and can access a smartphone or computer. The study will measure success by looking at changes in your symptoms and quality of life after 12 months. The current status of this study is unclear, but it plans to enroll 2000 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 2000 women.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your symptoms and quality of life will be measured at 12 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
At a glance
Conditions
NCT05953090
Where you'd take part
This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cahaba Dermatology & Skin Health Center
Birmingham, Alabamastudy coordinator listed
Recruiting
Southern Urogynecology
West Columbia, South Carolinastudy coordinator listed
Recruiting
Velvet Clinical Research
Burbank, Californiastudy coordinator listed
Recruiting
WR-Carolina Institute for Clinical Research
Fayetteville, North Carolinastudy coordinator listed
Recruiting
WR-Charleston Clinical Trials, LLC
Charleston, South Carolinastudy coordinator listed
Not yet recruiting
WR-Clinical Research Center of Nevada, LLC
Las Vegas, Nevadastudy coordinator listed
Not yet recruiting
WR-Global Medical Research, LLC
Dallas, Texasstudy coordinator listed
Recruiting
WR-Medical Research Center of Memphis, LLC
Memphis, Tennesseestudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Change in Vulvovaginal Symptoms Questionnaire (VSQ) score from baseline at 12 months.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 months12 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.