Wellnara Post-marketing Surveillance in Japan (WELLNARA)

Bayer

Status: Completed

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: E2/LNG oral (Wellnara, BAY86-5029)

Study type: Observational

Funder types: Industry

Identifiers

NCT01401114

15041

Details and patient eligibility

About

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.

Enrollment: 411 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received Wellnara for postmenopausal osteoporosis

Exclusion criteria

• Patients who are contraindicated based on the product label

Trial design

411 participants in 1 patient group

Group 1

Description:

Drug (incl. Placebo)

Treatment:

Drug: E2/LNG oral (Wellnara, BAY86-5029)