Phase 3
Completed N=120
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT01656161 ↗Enrolled (actual)
120
Serious AEs
14.2%
Results posted
Sep 2015
Primary outcomePrimary: Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L) — 98.33; 82.61 Percentage of Participants
Summary
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:
* achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days after investigational medicinal product (IMP) injection], and
* in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month 12 (Day 337) in participants with advanced prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L) |
98.33; 82.61 | — |
| 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 |
0.85; 87.83 | — |
| SECONDARY Percentage Change From Baseline in Prostate Specific Antigen (PSA) Through Day 337 |
-83.20; -83.48; -85.43; -82.89 | — |
| 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) |
1 | — |
| SECONDARY Testosterone Pharmacodynamic (PD) Metrics for First Injection: Area Under the Concentration vs Time Curve (AUC) |
224.13 | — |
| SECONDARY Testosterone PD Metrics for First Injection: Maximum Concentration (Cmax) |
16.52 | — |
| SECONDARY Testosterone PD Metrics for First Injection: Time to Peak Serum/Plasma Concentration (Tmax) |
48 | — |
| SECONDARY Testosterone PD Metrics for First Injection: Time to Castration (Tcast) |
18.01 | — |
| SECONDARY Triptorelin PK Metrics for Both Injections: Area Under the Concentration vs Time Curve (AUC) |
61.30; 66.44 | — |
| SECONDARY Triptorelin PK Metrics for Both Injections: Cmax |
16.77; 18.09 | — |
| SECONDARY Triptorelin PK Metrics for Both Injections: Concentration 0 Hour |
0.04; 0.07 | — |
Eligibility Criteria
Summary Inclusion Criteria:
- Meets protocol-specified criteria for qualification and contraception
- Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications
- Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures
Summary Exclusion Criteria:
- Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
- Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1) the safety or well-being of the participant or study staff; 2) the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3) the analysis of results
Data sourced from ClinicalTrials.gov (NCT01656161). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.