Trial Condition(s):

Osteoporosis, Postmenopausal

Wellnara post-marketing surveillance in Japan (WELLNARA)

Bayer Identifier:

15041

ClinicalTrials.gov Identifier:

NCT01401114

EudraCT Number:

Not Available

Study Completed

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 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.

Inclusion Criteria
-  Patients who received Wellnara for postmenopausal osteoporosis
Exclusion Criteria
-  Patients who are contraindicated based on the product label

Trial Summary

Enrollment Goal
411
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Wellnara (E2/LNG oral, BAY86-5029)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design