Clinical Trial: Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.

Detailed Summary:
Sponsor: Bayer

Current Primary Outcome: Incidence of adverse drug reactions and serious adverse events in subject who received Julina [ Time Frame: After Julina administration, upto 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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/wihtout vaginal atrophy at the end of Julina treatment [ Time Frame: At baseline and at end of Julina treatment, upto 1 year ]


Information By: Bayer

Dates:
Date Received: June 16, 2011
Date Started: October 2008
Date Completion:
Last Updated: July 10, 2012
Last Verified: July 2012