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NCT01386281: JULINA-CLIMA
Julina Post-marketing Surveillance for Climacteric Symptoms in Japan
trial testing E2 transdermal (Julina, BAY86-5435) in Osteoporosis, Postmenopausal in 506 participants. Completed in 15 April 2014.
15 April 2014
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 506 |
| Start date | 20 October 2008 |
| Primary completion | 15 April 2014 |
| Estimated completion | 15 April 2014 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- E2 transdermal (Julina, BAY86-5435) — full drug profile →
Conditions studied
- Osteoporosis, Postmenopausal — all drugs for Osteoporosis, Postmenopausal →
Sponsor
Bayer — full company profile →
Who can join
Eligibility, female only, with Osteoporosis, Postmenopausal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01386281
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoporosis, Postmenopausal
Currently open trials in the same condition.
- NCT07242612 — Bone Turnover Markers and Treatment Efficacy in Postmenopausal Osteoporosis · NA · recruiting
- NCT06558188 — Combined Anabolic Therapy · Phase 4 · recruiting
- NCT06655701 — Stress Urinary Incontinence and Sarcopenia in Postmenopausal Osteoporosis · recruiting
- NCT06525688 — New Biomarkers and Therapeutic Targets in Osteoporosis Via Omics Technologies · recruiting
- NCT05655013 — Treatment With Zoledronate Subsequent to Denosumab in Osteoporosis 2 (ZOLARMAB2) · Phase 4 · active not recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01386281 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 17 April 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01386281.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing