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| ID | Type | Description | Link |
|---|---|---|---|
| KRA75538 | Other Identifier | Quintiles |
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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg 6-month formulation administered by the subcutaneous (under the skin) route in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin embonate 22.5 mg | Experimental | Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin embonate 22.5 mg | Drug |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L) | within 337 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169 | on Days 1 and 169 | |
| Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337 |
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Summary Inclusion Criteria:
Summary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eija Lundstrom, MD | Debiopharm SA | Study Director |
| J. Bahlmann, MD | Private Practitioner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paarl Medical Centre | Paarl | Cape Town, Western Cape | 7646 | South Africa | ||
| Vergelegen Medi-Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10407987 | Background | Klippel KF, Winkler CJ, Jocham D, Rubben H, Moser B, Gulati A. [Effectiveness and tolerance of 1 dosage forms (subcutaneous and intramuscular) of decapeptyl depot in patients with advanced prostate carcinoma]. Urologe A. 1999 May;38(3):270-5. doi: 10.1007/s001200050280. German. | |
| 17096678 | Background | Tornoe CW, Agerso H, Senderovitz T, Nielsen HA, Madsen H, Karlsson MO, Jonsson EN. Population pharmacokinetic/pharmacodynamic (PK/PD) modelling of the hypothalamic-pituitary-gonadal axis following treatment with GnRH analogues. Br J Clin Pharmacol. 2007 Jun;63(6):648-64. doi: 10.1111/j.1365-2125.2006.02820.x. Epub 2006 Nov 10. |
| Label | URL |
|---|---|
| Company website | View source |
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Participants took part in the study at 10 hospital settings in South Africa, from 03 July 2012 to 30 August 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Triptorelin Embonate 22.5 mg | Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline through Day 337 |
| Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated) | Day 171 |
| Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC) | Days 1-169 |
| Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax) | Days 1-169 |
| Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax) | Days 1-169 |
| Testosterone PD Metrics for First Injection: Time to Castration (Tcast) | Days 1-169 |
| Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC) | Days 1-169 and Days 169-337 |
| Triptorelin PK Metrics for Both Injections: Cmax | Days 1-169 and Days 169-337 |
| Triptorelin PK Metrics for Both Injections: Concentration 0 Hour | Days 1-169 and Days 169-337 |
| Somerset West |
| Cape Town |
| 7130 |
| South Africa |
| Department of Urology, Tygerberg Hospital | Tygerberg | Cape Town | 7505 | South Africa |
| JCM Bahlmann | George | Eastern Cape | 6530 | South Africa |
| East Rand Urology Research Unit, Clinix Private Clinic | Johannesburg | Gautang | 1475 | South Africa |
| Clinresco Centres (Pty) Ltd | Kempton Park | Gauteng | 1619 | South Africa |
| Clinical Trial Unit, Room 2-54, Prinshof Medical Campus | Pretoria | Gauteng | 0002 | South Africa |
| Pretoria Urology Hospital | Pretoria | Gauteng | 0028 | South Africa |
| Wilmed Park Hospital | Klerksdorp | North West | 2571 | South Africa |
| New Groote Schuur Hospital, Division of Urology | Cape Town | 7925 | South Africa |
| Received Triptorelin at Day 1 |
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| Received Triptorelin at Day 169 |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set, defined as all enrolled subjects who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Triptorelin Embonate 22.5 mg | Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L) | Intention to treat population | Posted | Number | 95% Confidence Interval | Percentage of Participants | within 337 days |
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| Secondary | Percentage of Participants Showing ≤ 1.0 IU/L Increase in Serum Luteinising Hormone (LH) From 0 Hour to 2 Hours Post-injection on Day 1 and Day 169 | Intention to treat (ITT) population with a measured value at the time analysed | Posted | Number | 95% Confidence Interval | percentage of participants | on Days 1 and 169 |
|
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| Secondary | Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337 | ITT population with a measured value at each specified time point | Posted | Mean | Standard Deviation | percentage of change in PSA levels | Baseline through Day 337 |
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| Secondary | Number of Participants Who Presented a Real "Acute-on-chronic" (AOC) Phenomenon (Testosterone Levels ≥ 1.735 Nmol/L 48 Hours After the Second Injection While Previously Castrated) | Posted | Number | participants | Day 171 |
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| Secondary | Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC) | Posted | Geometric Mean | 95% Confidence Interval | day*nmol/L | Days 1-169 |
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| Secondary | Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax) | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | Days 1-169 |
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| Secondary | Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax) | PK/PD subset of 15 participants | Posted | Median | 95% Confidence Interval | hours | Days 1-169 |
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| Secondary | Testosterone PD Metrics for First Injection: Time to Castration (Tcast) | Posted | Geometric Mean | 95% Confidence Interval | days | Days 1-169 |
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| Secondary | Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC) | Posted | Geometric Mean | 95% Confidence Interval | days * ng/mL | Days 1-169 and Days 169-337 |
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| ||||||||||||||||||||||||||||||||||
| Secondary | Triptorelin PK Metrics for Both Injections: Cmax | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Days 1-169 and Days 169-337 |
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| Secondary | Triptorelin PK Metrics for Both Injections: Concentration 0 Hour | Participants in the PK/PD subset with a measured value. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Days 1-169 and Days 169-337 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Triptorelin Embonate 22.5 mg | Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169. | 17 | 120 | 117 | 120 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Death | General disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
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| Diabetic hyperglycaemic coma | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hip fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Meningitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Radius fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Lethargy | General disorders | MedDRA | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
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Agreement restricts the PI from discussing or publishing trial results after the trial is completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eija Lundstrom, Medical Director | Debiopharm International | +41 21 321 06 03 | eija.lundstrom@debiopharm.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| on Day 1 (n=118) |
| |||||
| on Day 169 (n=115) |
|
| Title | Denominators | Categories |
|---|
| at Day 85 (n=119) |
| |||||
| at Day 169 (n=117) |
| |||||
| at Day 253 (n=114) |
| |||||
| at Day 337 (n=113) |
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| Categories |
|---|
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| AUC(1-169) |
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| AUC(169-337) |
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| Categories |
|---|
| Days 1-169 |
| |||||
| Days 169-337 |
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| Categories |
|---|
| Days 1-169 |
| |||||
| Days 169-337 |
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