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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01386281
Other study ID # 15073
Secondary ID
Status Completed
Phase
First received June 16, 2011
Last updated April 16, 2018
Start date October 20, 2008
Est. completion date April 15, 2014

Study information

Verified date April 2018
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.


Recruitment information / eligibility

Status Completed
Enrollment 506
Est. completion date April 15, 2014
Est. primary completion date April 15, 2014
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

- Patients who are contraindicated based on the product label

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
E2 transdermal (Julina, BAY86-5435)
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions and serious adverse events in subject who received Julina After Julina administration, upto 1 year
Secondary Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina At baseline and after Julina administration, upto 1 year
Secondary Change from baseline in grad of hot flush and sweating at the end of Julina treatment At baseline and at end of Julina treatment, upto 1 year
Secondary Change from baseline in with/without vaginal atrophy at the end of Julina treatment At baseline and at end of Julina treatment, upto 1 year
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