Wellnara Post-marketing Surveillance in Japan (WELLNARA)
This study is currently recruiting participants.
Verified March 2013 by Bayer
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01401114
First received: July 22, 2011
Last updated: March 20, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis, Postmenopausal |
Drug: E2/LNG oral (Wellnara, BAY86-5029) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Drug Use Investigation of Wellnara Tablet |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara [ Time Frame: After Wellnara administration, up to 3 years ] [ Designated as safety issue: Yes ]
Secondary Outcome 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Group 1
Drug (incl. Placebo)
|
Drug: E2/LNG oral (Wellnara, BAY86-5029)
Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
Inclusion Criteria:
- Patients who received Wellnara for postmenopausal osteoporosis
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401114
Contacts
| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
Locations
| Japan | |
| Recruiting | |
| Many Locations, Japan | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Bayer Yakuhin Co.LTD. |
| ClinicalTrials.gov Identifier: | NCT01401114 History of Changes |
| Other Study ID Numbers: | 15041 |
| Study First Received: | July 22, 2011 |
| Last Updated: | March 20, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Bayer:
|
Wellnara Postmenopausal osteoporosis |
Additional relevant MeSH terms:
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013