check_circleStudy Completed
Contraception
Bayer Identifier:
16344
ClinicalTrials.gov Identifier:
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
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
757Trial Dates
May 2013 - May 2018Phase
N/ACould I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Contraceptive Efficacy by Number of unintended pregnanciesdate_rangeTime Frame:From 3 to 6 monthsenhanced_encryptionNoSafety Issue:
- Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet numberdate_rangeTime Frame:From 3 to 6 monthsenhanced_encryptionNoSafety Issue:
- 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 assessmentdate_rangeTime Frame:From 3 to 6 monthsenhanced_encryptionNoSafety Issue:
- Number of subjects with improved heavy menstrual bleedingdate_rangeTime Frame:From 3 to 6 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A