Post-market clinical follow-up (PMCF) study to demonstrate symptom improvement and tolerability of KadeFungin® Milchsäurekur in treatment / relapse prophylaxis of bacterial vaginosis

• Conditions: N76.0; Acute vaginitis

• Registration Number: DRKS00016985
• Lead Sponsor: DR. KADE Pharmazeutische Fabrik GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study Completion: 2019-10-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

Signed informed consent form (ICF) and data protective declaration
- Female patients aged =18 years
- Inclusion diagnosis: Sporadic acute bacterial vaginosis (BV) or acute episode of recurrent BV (rBV: = 2 BVs in the last 12 months); confirmed by e.g.:
* 3 of 4 Amsel criteria fulfilled and / or
* Nugent Score = 7
- Current medical conditions related to BV

Exclusion Criteria

- Patients with vulvovaginal candidiasis (VVC) or other vaginal infections
- Patients with known hypersensitivity to any of the ingredients
of KadeFungin® Milchsäurekur

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is defined as percentage of patients with improved symptoms from acute BV 10 days after V1 or last day of documentation in the diary, if documentation was discontinued earlier, i.e. no or only mild typical BV symptoms are present.