Julina Post-marketing Surveillance for Climacteric Symptoms in Japan (JULINA-CLIMA)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01386281
First received: June 16, 2011
Last updated: July 10, 2012
Last verified: July 2012
  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.


Condition Intervention
Osteoporosis, Postmenopausal
Drug: E2 transdermal (Julina, BAY86-5435)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse events in subject who received Julina [ Time Frame: After Julina administration, upto 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 506
Study Start Date: October 2008
Study Completion Date: April 2012
Groups/Cohorts Assigned Interventions
Group 1
Drug (incl. Placebo)
Drug: E2 transdermal (Julina, BAY86-5435)
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

  • Patients who are contraindicated based on the product label
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386281

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01386281     History of Changes
Other Study ID Numbers: 15073
Study First Received: June 16, 2011
Last Updated: July 10, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Julina
Postmenopausal osteoporosis

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014