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Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg

Information source: Ipsen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Martin Gerwe, MD, Study Director, Affiliation: Ipsen

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] for serum testosterone in patients with advanced prostate cancer.

Clinical Details

Official title: A Phase II, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).

Secondary outcome:

Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)

Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)

Maximum Concentration of Serum Testosterone [Cmax] - Raw Data

Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data

Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL

Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Kreiskrankenhaus, Abteilung Urologie, Bad Bergzabern 76887, Germany

Praxis für Urologie, Bad Ems, Germany

Praxis für Urologie, Bamberg 96047, Germany

Praxis für Urologie, Berlin, Germany

Praxis für Urologie, Braunschweig, Germany

Praxis für Urologie, Cham, Germany

Praxis für Urologie, Chemnitz, Germany

Praxis für Urologie, Dessau, Germany

Loretto Krankenhaus, Abteilung Urologie, Freiburg 79100, Germany

Praxis für Urologie, Gelsenkirchen, Germany

Praxis für Urologie, Herzberg, Germany

Praxis für Urologie, Lutherstadt Eisleben, Germany

Praxis für Urologie, Marburg, Germany

Praxis für Urologie, Markkleeberg, Germany

Praxis für Urologie, Miltenberg, Germany

Praxis für Urologie, Mülheim, Germany

Praxis für Urologie, München 81241, Germany

Praxis für Urologie, Neunkirchen, Germany

Urologische Klinik, Neunkirchen, Germany

Praxis für Urologie, Reutlingen 72764, Germany

Praxis für Urologie, Wesel, Germany

Praxis für Urologie, Wuppertal, Germany

Additional Information

Starting date: December 2010
Last updated: April 30, 2014

Page last updated: August 23, 2015

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