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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01257425
First received: December 8, 2010
Last updated: May 28, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • Pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve [AUC1-85days] for serum testosterone in patients with advanced prostate cancer. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of time to castration [tcast] in patients with advanced prostate cancer [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of the area under the curve [AUC1-169days] for testosterone [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Assessment of the area under the curve [AUC85-169days] for testosterone [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Assessment of the maximum concentration of serum testosterone [Cmax] [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 102
Study Start Date: December 2010
Study Completion Date: May 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM. Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.
Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC. Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)

Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.

Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257425

Locations
Germany
Kreiskrankenhaus, Abteilung Urologie
Bad Bergzabern, Germany, 76887
Praxis für Urologie
Bad Ems, Germany
Praxis für Urologie
Bamberg, Germany, 96047
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, Germany, 79100
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, Germany, 81241
Praxis für Urologie
Neunkirchen, Germany
Urologische Klinik
Neunkirchen, Germany
Praxis für Urologie
Reutlingen, Germany, 72764
Praxis für Urologie
Wesel, Germany
Praxis für Urologie
Wuppertal, Germany
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Martin Gerwe, MD Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01257425     History of Changes
Other Study ID Numbers: A-94-52014-178, 2010-019632-12
Study First Received: December 8, 2010
Last Updated: May 28, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Triptorelin
Luteolytic Agents
 Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 17, 2013