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CompletedNCT01797809Updated Apr 9, 2019

Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

An observational study in Contraception, sponsored by Bayer. Completed at 1 site in Korea, Republic of. Open to female participants. Per ClinicalTrials.gov, last updated 2019-04-09.

Sponsored by Bayer · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
757
Sex
Female
01

Study 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)

02

Conditions studied

  • Contraception
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Generally healthy women after menarche and before menopause desiring contraception with or without HMB will be recruited who are determined to start Qlaira

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

Exclusion Criteria:

  • All contraindications according to the local marketing authorization have to be considered.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
757 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

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

Interventions

  • DrugEV/DNG (Qlaira, BAY86-5027)

    Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)

    Time frame: Up to 6 months

Secondary outcomes

  1. Contraceptive Efficacy by Number of unintended pregnancies

    Time frame: From 3 to 6 months

  2. Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number

    Time frame: From 3 to 6 months

  3. 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

    Time frame: From 3 to 6 months

  4. Number of subjects with improved heavy menstrual bleeding

    Time frame: From 3 to 6 months

07

Study locations

1 site
  • Multiple Locations, Korea, Republic of
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01797809
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Feb 25, 2013
Start date
May 11, 2013
Primary completion
Jan 16, 2018
Completion
May 8, 2018
Last update
Apr 9, 2019

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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