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Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

NCT01386281 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 506

Last updated 2018-04-17

No results posted yet for this study

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

E2 transdermal (Julina, BAY86-5435)

Patients in daily life treatment receiving Julina for postmenopausal osteoporosis

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-20
Primary Completion
2014-04-15
Completion
2014-04-15

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386281 on ClinicalTrials.gov