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Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

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ClinicalTrials.gov Identifier: NCT01397955
Recruitment Status : Completed
First Posted : July 20, 2011
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Osteoporosis, Postmenopausal Drug: E2 transdermal (Julina, BAY86-5435)

Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Julina Tablets 0.5 mg (Postmenopausal Osteoporosis)
Study Start Date : January 2009
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1
Drug (incl. Placebo)
Drug: E2 transdermal (Julina, BAY86-5435)
Patients in daily life treatment receiving Julina for postmenopausal osteoporosis



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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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

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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01397955     History of Changes
Other Study ID Numbers: 15075
First Posted: July 20, 2011    Key Record Dates
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