Trials / Completed
CompletedNCT01397955
Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan
Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 148 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2 transdermal (Julina, BAY86-5435) | Patients in daily life treatment receiving Julina for postmenopausal osteoporosis |
Timeline
- Start date
- 2009-01-01
- Primary completion
- 2014-01-01
- Completion
- 2014-04-01
- First posted
- 2011-07-20
- Last updated
- 2015-04-17
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01397955. Inclusion in this directory is not an endorsement.