Julina Post-marketing Surveillance for Climacteric Symptoms in Japan

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.

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Key information

Conditions

Osteoporosis, Postmenopausal Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who received Julina for postmenopausal osteoporosis

Exclusion criteria

Patients who are contraindicated based on the product label

Treatment and study plan

E2 transdermal (Julina, BAY86-5435)

Drug

Patients in daily life treatment receiving Julina for postmenopausal osteoporosis

Primary outcomes

Incidence of adverse drug reactions and serious adverse events in subject who received Julina

Time frame: After Julina administration, upto 1 year

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: JULINA-CLIMA

Important dates

Study start: 2008
Primary completion: 2014
Study completion: 2014
First posted: Jul 1, 2011
Registry last updated: Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed