check_circleStudy Completed

Osteoporosis, postmenopausal

Bayer Identifier:

15041

ClinicalTrials.gov Identifier:

NCT01401114

EudraCT Number:

Not Available

EU CT Number:

Not Available
Wellnara post-marketing surveillance in Japan

Trial 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.

Key Participants Requirements

Sex

Female

Age

0 - N/A
  • - Patients who received Wellnara for postmenopausal osteoporosis
  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
411
Trial Dates
March 2009 - September 2014
Phase
N/A
Could I Receive a placebo
No
Products
Wellnara (E2/LNG oral, BAY86-5029)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

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

Secondary Outcome

  • Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Wellnara
    date_rangeTime Frame:
    At baseline and after Wellnara administration, up to 3 years
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    Safety Issue:
    Yes
  • Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse
    date_rangeTime Frame:
    At baseline and after Wellnara treatment, up to 3 years
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    Safety Issue:
    No

Trial design

Drug use investigation of Wellnara Tablet
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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