Wellnara Post-marketing Surveillance in Japan (WELLNARA)

September 25, 2015 updated by: Bayer

Drug Use Investigation of Wellnara Tablet

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

411

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Many Locations, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The target population of this study is patients who have received a prescription of Wellnara on the basis of the decision of the treating gynecologist. The study is expected to collect data of 400 patients in about 80 gynecological practices in Japan.

Description

Inclusion Criteria:

  • Patients who received Wellnara for postmenopausal osteoporosis

Exclusion Criteria:

  • Patients who are contraindicated based on the product label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug (incl. Placebo)
Drug: E2/LNG oral (Wellnara, BAY86-5029)
Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
At baseline and after Wellnara treatment, up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

July 22, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (ESTIMATE)

July 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 25, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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