Status:
COMPLETED
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
Lead Sponsor:
Ipsen
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\...
Eligibility Criteria
Inclusion
- Histologically or cytologically proven prostate cancer, locally advanced or metastatic, or rising PSA (prostate-specific antigen) after failed local therapy, and the patient scheduled to receive androgen deprivation therapy
- Serum testosterone levels ≥ 125 ng/dl (1.25 ng/ml, 1.25 microg/l, 4.3 nmol/l) measured by any laboratory or on site within the previous 6 months or at study start
- Karnofsky performance index \> 70
- Expected survival ≥ 9 months
Exclusion
- Prior hormonal treatment for prostate cancer including gonadotropin-releasing hormone (GnRH) agonists or antagonists within the last 12 months preceding the study or concomitant treatment with one or more of these substance(s)
- Any current use or within 6 months prior to treatment start of medications which are known to affect the metabolism and/or secretion of androgenic hormones: ketoconazole, aminoglutethimide, oestrogens and progesterone
- Patient at risk of spinal cord compression or ureter obstruction
- Prior hypophysectomy or adrenalectomy
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT01257425
Start Date
December 1 2010
End Date
May 1 2012
Last Update
February 8 2019
Active Locations (22)
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1
Kreiskrankenhaus, Abteilung Urologie
Bad Bergzaben, Germany, 76887
2
Praxis für Urologie
Bad Ems, Germany
3
Praxis für Urologie
Bamberg, Germany, 96047
4
Praxis für Urologie
Berlin, Germany