Trial record 7 of 171 for:
"Osteoporosis, Postmenopausal"
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan (JULINA-CLIMA)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01386281
First received: June 16, 2011
Last updated: July 10, 2012
Last verified: July 2012
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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 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 May 16, 2013