Trial Condition(s):
Contraception
Qlaira rPMS (Regulatory Post Marketing Surveillance) Study in Korea
Bayer Identifier:
16344
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
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)
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.
Trial Summary
Enrollment Goal
757
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: (+)1-888-84-22937 |
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:
1
Primary Outcome
- Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)Timeframe: Up to 6 months
Secondary Outcome
- Contraceptive Efficacy by Number of unintended pregnanciesTimeframe: From 3 to 6 months
- Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet numberTimeframe: 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 assessmentTimeframe: From 3 to 6 months
- Number of subjects with improved heavy menstrual bleedingTimeframe: From 3 to 6 months
Additional Information
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