- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257425
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg (PAMIS)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Bad Bergzabern, Germany, 76887
- Kreiskrankenhaus, Abteilung Urologie
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Bad Ems, Germany
- Praxis für Urologie
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Bamberg, Germany, 96047
- Praxis für Urologie
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Berlin, Germany
- Praxis für Urologie
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Braunschweig, Germany
- Praxis für Urologie
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Cham, Germany
- Praxis für Urologie
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Chemnitz, Germany
- Praxis für Urologie
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Dessau, Germany
- Praxis für Urologie
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Freiburg, Germany, 79100
- Loretto Krankenhaus, Abteilung Urologie
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Gelsenkirchen, Germany
- Praxis für Urologie
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Herzberg, Germany
- Praxis für Urologie
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Lutherstadt Eisleben, Germany
- Praxis für Urologie
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Marburg, Germany
- Praxis für Urologie
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Markkleeberg, Germany
- Praxis für Urologie
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Miltenberg, Germany
- Praxis für Urologie
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Mülheim, Germany
- Praxis für Urologie
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München, Germany, 81241
- Praxis für Urologie
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Neunkirchen, Germany
- Praxis für Urologie
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Neunkirchen, Germany
- Urologische Klinik
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Reutlingen, Germany, 72764
- Praxis für Urologie
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Wesel, Germany
- Praxis für Urologie
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Wuppertal, Germany
- Praxis für Urologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
|
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. |
Other: Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
|
Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing.
From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods.
This value was log-transformed to more closely meet the assumption of the statistical method.
|
1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve of Testosterone Serum Concentration Between D1 and D169 (AUC1-169d)
Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
|
Area under the curve calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 169 after dosing.
From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods.
This value was log-transformed to more closely meet the assumption of the statistical method.
|
1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
|
Area Under the Curve of Testosterone Serum Concentration Between D85 and D169 (AUC85-169d)
Time Frame: 85, 87, 113, 141 and 169 days post-dose
|
Area under the curve calculated from serum testosterone concentration taken at intervals between Day 85 and Day 169 after dosing.
From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods.
This value was log-transformed to more closely meet the assumption of the statistical method.
|
85, 87, 113, 141 and 169 days post-dose
|
Maximum Concentration of Serum Testosterone [Cmax] - Raw Data
Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
|
Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
|
1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
|
Maximum Concentration of Serum Testosterone [Cmax] - Log-transformed Data
Time Frame: 1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
|
Cmax was assessed as the maximum testosterone serum concentration between the first administration of the study drug and Day 169.
|
1, 3, 5, 8, 15, 22, 29, 57, 85, 87, 113, 141 and 169 days post-dose
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Time to Castration [Tcast] - Testosterone Level Less Than or Equal to 0.5 ng/mL
Time Frame: 12 weeks
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tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than or equal to 0.5 ng/mL for the first time.
Analysis of tcast was based on the Kaplan-Meier estimator.
|
12 weeks
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Time to Castration [Tcast] - Testosterone Level Less Than 0.5 ng/mL
Time Frame: 12 weeks
|
tcast is the number of days between day of first administration of the study drug and the day the testosterone level reaches the limit of castration defined as testosterone level less than 0.5 ng/mL for the first time.
Analysis of tcast was based on the Kaplan-Meier estimator.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Luteolytic Agents
- Triptorelin Pamoate
Other Study ID Numbers
- A-94-52014-178
- 2010-019632-12 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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