Post-market clinical follow-up (PMCF) study to observe the course of symptoms of vulvovaginal dryness in patients receiving therapy with KadeFungin® Befeuchtungsgel
- Conditions
- N89.8Other specified noninflammatory disorders of vagina
- Registration Number
- DRKS00017248
- Lead Sponsor
- DR. KADE Pharmazeutische Fabrik GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
Signed informed consent form (ICF) and data protective declaration
- Female patients aged =18 years
- Inclusion diagnosis: Symptomatic vulvar and / or vaginal dryness
Exclusion Criteria
- Patients with confirmed vaginal infections or other vaginal or vulvar disorders
- Patients with known hypersensitivity to any of the ingredients of KadeFungin® Befeuchtungsgel
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is defined as the percentage of patients with improved symptoms due to vulvar and/or vaginal dryness and associated symptoms, i.e. if no or only mild symptoms are present, on Day 14 or last day of documentation in the diary, if documentation was discontinued earlier.
- Secondary Outcome Measures
Name Time Method