Wellnara Post-marketing Surveillance in Japan

Completed

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: E2/LNG oral (Wellnara, BAY86-5029)

• Registration Number: NCT01401114
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 411

Inclusion Criteria

• Patients who received Wellnara 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/LNG oral (Wellnara, BAY86-5029)	Drug (incl. Placebo)

Primary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara	After Wellnara administration, up to 3 years

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnara	At baseline and after Wellnara administration, up to 3 years
Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse	At baseline and after Wellnara treatment, up to 3 years