check_circleStudy Completed

Contraception

Bayer Identifier:

16344

ClinicalTrials.gov Identifier:

NCT01797809

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Additional Information

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