check_circleStudy Completed
Endometriosis
Bayer Identifier:
16625
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Key Participants Requirements
Sex
FemaleAge
0 - N/ATrial summary
Enrollment Goal
3223Trial Dates
July 2013 - August 2017Phase
N/ACould I Receive a placebo
NoProducts
Visanne (Dienogest, BAY86-5258)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerabilitydate_rangeTime Frame:up to 1 yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study populationdate_rangeTime Frame:6 months and 1 yearenhanced_encryptionNoSafety Issue:
- Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).date_rangeTime Frame:6 months and 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A