Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

Osteoporosis, Postmenopausal Clinical Trial

— JULINA-CLIMA  

Official title:

Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01386281
• Other study ID #: 15073
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

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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