Post-market clinical follow-up (PMCF) study to observe the course of symptoms of vulvovaginal dryness in patients receiving therapy with KadeFungin® Befeuchtungsgel

Post-market clinical follow-up (PMCF) study to observe the course of symptoms of vulvovaginal dryness in patients receiving therapy with KadeFungin® Befeuchtungsgel - DRYLESS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00017248

Enrollment

100

Registered

2019-05-06

Start date

2019-05-09

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

N89.8

Interventions

Group 1: Treatment with KadeFungin® Befechtungsgel In the scope of this observational study no intervention is planned. The recommendation of application of KadeFungin® Befeuchtungsgel will take plac

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: Symptomatic vulvar and / or vaginal dryness

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
The following secondary endpoints will be evaluated: - 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, at any time during the observational period - Percentage of patients with no symptoms due to vulvar and/or vaginal dryness on Day 14 or last day of documentation in the diary, if documentation was discontinued earlier (symptom-free) - Time to (first having) improved symptoms, time to (first being) symptom-free - Course of typical symptoms of vulvar and/or vaginal dryness assessed by patients (sum-score, individual scores) - Percentage of patients with 50% reduction from Baseline in sum-score of typical symptoms of vulvar and/or vaginal dryness on Day 14 or last day of documentation in the diary, if documentation was discontinued earlier - Evaluation of the efficacy by physician The following further endpoints will be evaluated: - Satisfaction with the moisturizing effect by the patient - Application of KadeFungin® Befeuchtungsgel as described in the user manual - Product handling The following further endpoints will be evaluated: - Untoward medical occurrences, ADEs and device deficiencies - Evaluation of the local tolerability by the patient and by the physician	—

Measure

Time frame

The following secondary endpoints will be evaluated: - 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, at any time during the observational period - Percentage of patients with no symptoms due to vulvar and/or vaginal dryness on Day 14 or last day of documentation in the diary, if documentation was discontinued earlier (symptom-free) - Time to (first having) improved symptoms, time to (first being) symptom-free - Course of typical symptoms of vulvar and/or vaginal dryness assessed by patients (sum-score, individual scores) - Percentage of patients with 50% reduction from Baseline in sum-score of typical symptoms of vulvar and/or vaginal dryness on Day 14 or last day of documentation in the diary, if documentation was discontinued earlier - Evaluation of the efficacy by physician The following further endpoints will be evaluated: - Satisfaction with the moisturizing effect by the patient - Application of KadeFungin® Befeuchtungsgel as described in the user manual - Product handling The following further endpoints will be evaluated: - Untoward medical occurrences, ADEs and device deficiencies - Evaluation of the local tolerability by the patient and by the physician

—

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