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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016985

Enrollment

100

Registered

2019-03-19

Start date

2019-03-25

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

N76.0

Interventions

Group 1: In the scope of this observational study no intervention is planned. The recommendation of application of KadeFungin® Milchsäurekur will take place before and regardless of the participation

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
The following secondary endpoints will be evaluated: 1. Percentage of patients symptom-free from acute BV 10 days after V1, or last day of documentation in the diary, if documentation was discontinued earlier, i.e. no typical BV symptoms are present 2. Time to (first having) improved symptoms, time to (first being) symptom-free. 3. Course of typical BV symptoms assessed by patients (sum-score, individual scores) using both original data and LOCF imputation 4. Percentage of patients with 50% reduction from Baseline in typical BV symptom sum-score 10 days after V1 or last day of documentation in the diary, if documentation was discontinued earlier 5. Percentage of patients with negative outcome of each of the 4 Amsel criterions separately at V2 6. Percentage of patients with Nugent score 0-6 at V2 7. Percentage of patients with clinical cure (no Amsel criterion present) at V2 8. Percentage of patients with therapeutic cure (clinical cure and Nugent score 0-3) at V2 9. Change in percentage of patients with pH-Value =4.5/>4.5 from Baseline to V2 10. Percentages of patients without BV relapse after 1, 2 or 3 months 11. Satisfaction with the therapeutic effect 12. Satisfaction with the prophylactic effect Further endpoints (handling, safety): - Moisturizing effect of KadeFungin® Milchsäurekur - Application of KadeFungin® Milchsäurekur as described in the user manual - Handling of KadeFungin® Milchsäurekur - Evaluation of the local tolerability - Occurrence of AEs	—

Measure

Time frame

The following secondary endpoints will be evaluated: 1. Percentage of patients symptom-free from acute BV 10 days after V1, or last day of documentation in the diary, if documentation was discontinued earlier, i.e. no typical BV symptoms are present 2. Time to (first having) improved symptoms, time to (first being) symptom-free. 3. Course of typical BV symptoms assessed by patients (sum-score, individual scores) using both original data and LOCF imputation 4. Percentage of patients with 50% reduction from Baseline in typical BV symptom sum-score 10 days after V1 or last day of documentation in the diary, if documentation was discontinued earlier 5. Percentage of patients with negative outcome of each of the 4 Amsel criterions separately at V2 6. Percentage of patients with Nugent score 0-6 at V2 7. Percentage of patients with clinical cure (no Amsel criterion present) at V2 8. Percentage of patients with therapeutic cure (clinical cure and Nugent score 0-3) at V2 9. Change in percentage of patients with pH-Value =4.5/>4.5 from Baseline to V2 10. Percentages of patients without BV relapse after 1, 2 or 3 months 11. Satisfaction with the therapeutic effect 12. Satisfaction with the prophylactic effect Further endpoints (handling, safety): - Moisturizing effect of KadeFungin® Milchsäurekur - Application of KadeFungin® Milchsäurekur as described in the user manual - Handling of KadeFungin® Milchsäurekur - Evaluation of the local tolerability - Occurrence of AEs

—

Countries

Germany

Contacts

Public ContactBettina Schopf

Pharmalog Institut für klinische Forschung GmbH

schopf@pharmalog.com+49 (0) 89 544637-53

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026