Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
Completed
- Conditions
- Osteoporosis, Postmenopausal
- Interventions
- Drug: E2 transdermal (Julina, BAY86-5435)
- Registration Number
- NCT01386281
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 506
Inclusion Criteria
- Patients who received Julina for postmenopausal osteoporosis
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Exclusion Criteria
- Patients who are contraindicated based on the product label
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 E2 transdermal (Julina, BAY86-5435) Drug (incl. Placebo)
- Primary Outcome Measures
Name Time Method Incidence of adverse drug reactions and serious adverse events in subject who received Julina After Julina administration, upto 1 year
- Secondary Outcome Measures
Name Time Method Change from baseline in with/without vaginal atrophy at the end of Julina treatment At baseline and at end of Julina treatment, upto 1 year Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina At baseline and after Julina administration, upto 1 year Change from baseline in grad of hot flush and sweating at the end of Julina treatment At baseline and at end of Julina treatment, upto 1 year