Clinical trial · Interventional
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
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
- 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 purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients 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 Pamoate (Pamorelin® LA 11.25 mg) | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.
- interventionNames
- Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
- type
- OTHER
- label
- Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.
- interventionNames
- Drug: Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Primary outcomes (1)
- measure
- Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
- timeFrame
- 1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available