check_circleStudy Completed
Postmenopausal Period, Osteoporosis, Postmenopausal
Bayer Identifier:
14841
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Angeliq regulatory Post Marketing Surveillance
Trial purpose
Angeliq regulatory Post-Marketing Surveillance (PMS) is to get data about safety and efficacy in real practice for the indication approved by Korea Food and Drug Administration (KFDA). This is non-interventional , prospective, multi-center study.Target number of patients is 4500.
Key Participants Requirements
Sex
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
4078Trial Dates
June 2007 - December 2012Phase
N/ACould I Receive a placebo
NoProducts
Angeliq (E2/DRSP, BAY86-4891)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- Adverse event collectiondate_rangeTime Frame:At each visit of patient during observational period (6 months)enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Improvement of menopausal symptomsdate_rangeTime Frame:After 6 months or at discontinuation of Angeliq (At earlier point)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A