check_circleStudy Completed

Contraception

Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

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)

Key Participants Requirements

Sex

Female

Age

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

Trial summary

Enrollment Goal
757
Trial Dates
May 2013 - May 2018
Phase
N/A
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
    date_rangeTime Frame:
    Up to 6 months
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    Safety Issue:
    Yes

Secondary Outcome

  • Contraceptive Efficacy by Number of unintended pregnancies
    date_rangeTime Frame:
    From 3 to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number
    date_rangeTime Frame:
    From 3 to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • The relief of heavy menstrual bleeding symptom also will be calculated as an efficacy variable from admission to the study until final visit by subject’s assessment
    date_rangeTime Frame:
    From 3 to 6 months
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    Safety Issue:
    No
  • Number of subjects with improved heavy menstrual bleeding
    date_rangeTime Frame:
    From 3 to 6 months

Trial design

Qlaira® 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