Clinical trial · Interventional
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
A Multicentre, Open, Non-comparative, Phase III Study on the Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 22.5 mg 6-month Formulation in Patients With Advanced Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Triptorelin embonate 22.5 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Triptorelin embonate 22.5 mg
- description
- Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
- interventionNames
- Drug: Triptorelin embonate 22.5 mg
Primary outcomes (1)
- measure
- Percentage of Participants Achieving and Maintaining Castrate Levels of Serum Testosterone (<1.735 Nmol/L)
- timeFrame
- within 337 days
Secondary outcomes (10)
- measure
- 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
- timeFrame
- on Days 1 and 169
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDKlippel 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. PMID 10407987
- BACKGROUNDTornoe 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. PMID 17096678