Trials / Completed
CompletedNCT01401114
Wellnara Post-marketing Surveillance in Japan
Drug Use Investigation of Wellnara Tablet
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 411 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E2/LNG oral (Wellnara, BAY86-5029) | Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2014-08-01
- Completion
- 2014-09-01
- First posted
- 2011-07-25
- Last updated
- 2015-09-28
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01401114. Inclusion in this directory is not an endorsement.