check_circleStudy Completed

Endometriosis

Bayer Identifier:
16625
ClinicalTrials.gov Identifier:
NCT01788722
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

Female

Age

0 - N/A
  • - 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
  • - All contraindications according to the local marketing authorization have to be considered.

Trial summary

Enrollment Goal
3223
Trial Dates
July 2013 - August 2017
Phase
N/A
Could I Receive a placebo
No
Products
Visanne (Dienogest, BAY86-5258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 tolerability
    date_rangeTime Frame:
    up to 1 year
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population
    date_rangeTime Frame:
    6 months and 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).
    date_rangeTime Frame:
    6 months and 1 year
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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