Trial Condition(s):

Contraception

Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

Bayer Identifier:

16344

ClinicalTrials.gov Identifier:

NCT01797809

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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)

Inclusion Criteria
- 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 Criteria
- All contraindications according to the local marketing authorization have to be considered.

Trial Summary

Enrollment Goal
757
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, South Korea

Status
Completed
 

Trial Design