check_circleStudy Completed
Contraception, Premenstrual Syndrome, Acne
Bayer Identifier:
14785
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Regulatory Post marketing Surveillance Study on YAZ
Trial purpose
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
Key Participants Requirements
Sex
FemaleAge
18 - 50 YearsTrial summary
Enrollment Goal
770Trial Dates
July 2009 - November 2011Phase
N/ACould I Receive a placebo
NoProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- Adverse event collectiondate_rangeTime Frame:After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)enhanced_encryptionyesSafety Issue:
- Contraception efficacydate_rangeTime Frame:After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)enhanced_encryptionnoSafety Issue:
- Drug compliancedate_rangeTime Frame:After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)enhanced_encryptionnoSafety Issue:
- Release of Premenstrual Dysphoric Disorder (PMDD) or acnedate_rangeTime Frame:After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Number of patients who used YAZ just for contraceptiondate_rangeTime Frame:At initial visit (Day 0)enhanced_encryptionnoSafety Issue:
- Number of patients who used YAZ for PMDD + contraceptiondate_rangeTime Frame:At initial visit (Day 0)enhanced_encryptionnoSafety Issue:
- Number of patients who used YAZ for Acne + contraceptiondate_rangeTime Frame:At initial visit (Day 0)enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A