Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

Overview

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.

Full Title of Study: “Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 15, 2014

Interventions

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

Arms, Groups and Cohorts

  • Group 1
    • Drug (incl. Placebo)

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of adverse drug reactions and serious adverse events in subject who received Julina
    • Time Frame: After Julina administration, upto 1 year

Secondary Measures

  • Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease) and dose of Julina
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: At baseline and at end of Julina treatment, upto 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria

  • Patients who are contraindicated based on the product label

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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