Wellnara Post-marketing Surveillance in Japan

NCT01401114 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 411

Last updated 2015-09-28

No results posted yet for this study

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

  • Osteoporosis, Postmenopausal

Interventions

DRUG

E2/LNG oral (Wellnara, BAY86-5029)

Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Japan

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01401114 on ClinicalTrials.gov