Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea

Contraception Clinical Trial

Official title:

Qlaira® Regulatory Post Marketing Surveillance Study in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797809
• Other study ID #: 16344
• Secondary ID: QL1212KR
• Status: Completed
• Start date: May 11, 2013
• Est. completion date: May 8, 2018

Study information

• Verified date: March 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 757
• Est. completion date: May 8, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• EV/DNG (Qlaira, BAY86-5027)
Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)		Up to 6 months
Secondary	Contraceptive Efficacy by Number of unintended pregnancies		From 3 to 6 months
Secondary	Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number		From 3 to 6 months
Secondary	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
Secondary	Number of subjects with improved heavy menstrual bleeding		From 3 to 6 months

External Links

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