Status:
COMPLETED
Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
Brief Summary
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)
Eligibility Criteria
Inclusion
- Signed and dated informed consent
- Women after menarche and before menopause
- Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception
- Women who are prescribed Qlaira® for the first time, during the study period
Exclusion
- \- All contraindications according to the local marketing authorization have to be considered.
Key Trial Info
Start Date :
May 11 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2018
Estimated Enrollment :
757 Patients enrolled
Trial Details
Trial ID
NCT01797809
Start Date
May 11 2013
End Date
May 8 2018
Last Update
April 9 2019
Active Locations (1)
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1
Multiple Locations, South Korea