check_circleStudy Completed
Osteoporosis, postmenopausal
Bayer Identifier:
15073
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Julina post-marketing surveillance for climacteric symptoms 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 Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.
Key Participants Requirements
Sex
FemaleAge
0 - N/ATrial summary
Enrollment Goal
506Trial Dates
October 2008 - April 2014Phase
N/ACould I Receive a placebo
NoProducts
Julina (Estradiol, BAY86-5435)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 Julinadate_rangeTime Frame:After Julina administration, upto 1 yearenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julinadate_rangeTime Frame:At baseline and after Julina administration, upto 1 yearenhanced_encryptionYesSafety Issue:
- Change from baseline in grad of hot flush and sweating at the end of Julina treatmentdate_rangeTime Frame:At baseline and at end of Julina treatment, upto 1 yearenhanced_encryptionNoSafety Issue:
- Change from baseline in with/without vaginal atrophy at the end of Julina treatmentdate_rangeTime Frame:At baseline and at end of Julina treatment, upto 1 yearenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A