check_circleStudy Completed
Osteoporosis, postmenopausal
Bayer Identifier:
15041
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Wellnara post-marketing surveillance in Japan
Trial purpose
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Wellnara for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Wellnara in clinical practice. A total 400 patients will be recruited and followed 3 years since starting Wellnara administration.
Key Participants Requirements
Sex
FemaleAge
0 - N/ATrial summary
Enrollment Goal
411Trial Dates
March 2009 - September 2014Phase
N/ACould I Receive a placebo
NoProducts
Wellnara (E2/LNG oral, BAY86-5029)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subject who received Wellnaradate_rangeTime Frame:After Wellnara administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnaradate_rangeTime Frame:At baseline and after Wellnara administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
- Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worsedate_rangeTime Frame:At baseline and after Wellnara treatment, up to 3 yearsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A