check_circleStudy Completed

Osteoporosis, postmenopausal

Bayer Identifier:

15073

ClinicalTrials.gov Identifier:

NCT01386281

EudraCT Number:

Not Available

EU CT Number:

Not Available
Julina post-marketing surveillance for climacteric symptoms 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 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.

Key Participants Requirements

Sex

Female

Age

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

Trial summary

Enrollment Goal
506
Trial Dates
October 2008 - April 2014
Phase
N/A
Could I Receive a placebo
No
Products
Julina (Estradiol, BAY86-5435)
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 Julina
    date_rangeTime Frame:
    After Julina administration, upto 1 year
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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 Julina
    date_rangeTime Frame:
    At baseline and after Julina administration, upto 1 year
    enhanced_encryption
    Safety Issue:
    Yes
  • Change from baseline in grad of hot flush and sweating at the end of Julina treatment
    date_rangeTime Frame:
    At baseline and at end of Julina treatment, upto 1 year
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in with/without vaginal atrophy at the end of Julina treatment
    date_rangeTime Frame:
    At baseline and at end of Julina treatment, upto 1 year
    enhanced_encryption
    Safety Issue:
    No

Trial design

Drug use investigation of Julina Tablets 0.5 mg (postmenopausal osteoporosis)
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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