Trial Condition(s):
Endometriosis
Regulatory Post Marketing Surveillance Study in Korea
Bayer Identifier:
16625
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and – for a subset of patients – at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.
Inclusion Criteria
- Signed and dated informed consent - Women diagnosed by a physician as having endometriosis - Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period
Exclusion Criteria
- All contraindications according to the local marketing authorization have to be considered.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
Visanne® (dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerabilityTimeframe: up to 1 year
Secondary Outcome
- Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study populationTimeframe: 6 months and 1 year
- Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).Timeframe: 6 months and 1 year
Additional Information
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