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Wellnara Post-marketing Surveillance in Japan (WELLNARA)

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ClinicalTrials.gov Identifier: NCT01401114
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment
Osteoporosis, Postmenopausal Drug: E2/LNG oral (Wellnara, BAY86-5029)

Study Type : Observational
Actual Enrollment : 411 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Wellnara Tablet
Study Start Date : March 2009
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




Primary Outcome Measures :
  1. Incidence of adverse drug reactions and serious adverse events in subject who received Wellnara [ Time Frame: After Wellnara administration, up to 3 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401114


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01401114     History of Changes
Other Study ID Numbers: 15041
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Bayer:
Wellnara
Postmenopausal osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases