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Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01397955
First Posted: July 20, 2011
Last Update Posted: April 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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 3 years ]

Secondary Outcome Measures:
  • Incidence of adverse drug reactions in subpopulation with baseline data (such as demographic data, concomitant disease, hysterectomy) and dose of Julina [ Time Frame: At baseline and after Julina administration, upto 3 years ]
  • Effectiveness evaluation assessment by the three rank scales: improvement, not changed, and worse [ Time Frame: At baseline and at end of Julina treatment, upto 3 years ]

Enrollment: 148
Study Start Date: January 2009
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397955


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01397955     History of Changes
Other Study ID Numbers: 15075
First Submitted: July 19, 2011
First Posted: July 20, 2011
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Bayer:
Julina
Postmenopausal osteoporosis

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