Trial Condition(s):
Osteoporosis, Postmenopausal
Julina post-marketing surveillance for climacteric symptoms in Japan (JULINA-CLIMA)
Bayer Identifier:
15073
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients who received Julina for postmenopausal osteoporosis
Exclusion Criteria
- Patients who are contraindicated based on the product label
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Drug use investigation of Julina Tablets 0.5 mg (postmenopausal osteoporosis)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subject who received JulinaTimeframe: After Julina administration, upto 1 year
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of JulinaTimeframe: At baseline and after Julina administration, upto 1 year
- Change from baseline in grad of hot flush and sweating at the end of Julina treatmentTimeframe: At baseline and at end of Julina treatment, upto 1 year
- Change from baseline in with/without vaginal atrophy at the end of Julina treatmentTimeframe: At baseline and at end of Julina treatment, upto 1 year
Additional Information
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