NCT01797809

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2013

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed
Last Updated

April 9, 2019

Status Verified

March 1, 2019

Enrollment Period

4.7 years

First QC Date

February 21, 2013

Last Update Submit

April 5, 2019

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

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

    Up to 6 months

Secondary Outcomes (4)

  • Contraceptive Efficacy by Number of unintended pregnancies

    From 3 to 6 months

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

    From 3 to 6 months

  • 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

    From 3 to 6 months

  • Number of subjects with improved heavy menstrual bleeding

    From 3 to 6 months

Study Arms (1)

Group 1

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

Interventions

EV/DNG (Qlaira, BAY86-5027)DRUG

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

Group 1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Multiple Locations, South Korea

Location

Related Links

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 25, 2013

Study Start

May 11, 2013

Primary Completion

January 16, 2018

Study Completion

May 8, 2018

Last Updated

April 9, 2019

Record last verified: 2019-03

Locations

KR(1)