Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
NCT ID: NCT01257425
Last Updated: 2019-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
109 participants
INTERVENTIONAL
2010-12-31
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
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.
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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Kreiskrankenhaus, Abteilung Urologie
Bad Bergzaben, , Germany
Praxis für Urologie
Bad Ems, , Germany
Praxis für Urologie
Bamberg, , 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
Praxis für Urologie
Eisleben Lutherstadt, , Germany
Loretto Krankenhaus, Abteilung Urologie
Freiburg im Breisgau, , Germany
Praxis für Urologie
Gelsenkirchen, , Germany
Praxis für Urologie
Herzberg, , 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
Praxis für Urologie
Neunkirchen, , Germany
Urologische Klinik
Neunkirchen, , Germany
Praxis für Urologie
Reutlingen, , Germany
Praxis für Urologie
Wesel, , Germany
Praxis für Urologie
Wuppertal, , Germany
Countries
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Other Identifiers
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2010-019632-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A-94-52014-178
Identifier Type: -
Identifier Source: org_study_id
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