Wellnara Post-marketing Surveillance in Japan

Overview

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.

Full Title of Study: “Drug Use Investigation of Wellnara Tablet”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: E2/LNG oral (Wellnara, BAY86-5029)
    • Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis

Arms, Groups and Cohorts

  • Group 1
    • Drug (incl. Placebo)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who received Wellnara for postmenopausal osteoporosis Exclusion Criteria:

  • Patients who are contraindicated based on the product label

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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