Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

Bayer

Status: Completed

Conditions: Contraception

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027)

Study type: Observational

Funder types: Industry

Identifiers

NCT01797809

QL1212KR (Other Identifier)

16344

Details and patient eligibility

About

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)

Enrollment: 757 patients

Sex: Female

Volunteers: No Healthy Volunteers

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 design

757 participants in 1 patient group

Group 1

Treatment:

Drug: EV/DNG (Qlaira, BAY86-5027)