Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
JULINA-CLIMA
Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
1 other identifier
observational
506
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 20, 2008
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2014
CompletedApril 17, 2018
April 1, 2018
5.5 years
June 16, 2011
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of adverse drug reactions and serious adverse events in subject who received Julina
After Julina administration, upto 1 year
Secondary Outcomes (3)
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
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
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
Study Arms (1)
Group 1
Drug (incl. Placebo)
Interventions
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis
Eligibility Criteria
The target population of this study is patients who have received a prescription of Julina on the basis of the decision of the treating gynecologist. The study is expected to collect data of 100 patients in about 20 gynecological practices in Japan.
You may qualify if:
- Patients who received Julina for postmenopausal osteoporosis
You may not qualify if:
- Patients who are contraindicated based on the product label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Multiple Locations, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
July 1, 2011
Study Start
October 20, 2008
Primary Completion
April 15, 2014
Study Completion
April 15, 2014
Last Updated
April 17, 2018
Record last verified: 2018-04