Trial Condition(s):
Endometriosis
Regulatory Post Marketing Surveillance Study in Korea
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 | Status | ||
|---|---|---|---|
Locations Investigative Site Many Locations, South Korea | Status Completed | 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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