Clinical trial · Interventional
Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer
NCT01161563CI-TRIAL-00012023completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 compare how subjects feel after receiving injections of two different types of GnRH six months apart. One injection is given under the skin of the abdomen, and the other one into the muscle of the buttock or thigh.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide acetate | Drug | Leuprolide | ALIAS |
| Triptorelin pamoate | Drug | Triptorelin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Leuprolide acetate
- description
- Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area. Injection occurred either 6 months before or 6 months after injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
- interventionNames
- Drug: Leuprolide acetate
- type
- ACTIVE_COMPARATOR
- label
- Triptorelin pamoate
- description
- Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock. Injection occurred either 6 months before or 6 months after injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
- interventionNames
- Drug: Triptorelin pamoate
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male patients with a diagnosis of advanced prostate cancer for whom treatment with triptorelin pamoate or leuprolide acetate is indicated; * At least 18 years of age; * Life expectancy of at least 1 year; * Capable of completing the study questionnaires without assistance. Exclusion Criteria: * Patients for whom treatment with triptorelin pamoate or leuprolide acetate is contraindicated; * Known hypersensitivity to triptorelin, leuprolide or any other GnRH or luteinizing hormone releasing hormone (LHRH) agonists, or GnRH or LHRH; * Clinically significant systemic disease or condition that would, in the investigator's opinion, lead to undue risk following administration of either triptorelin or leuprolide; * History of alcohol/drug abuse within the past year; * History of significant medical problems that may confound the outcome of this study; * Requires concomitant medications that may affect study assessments (e.g., topical medications used for pretreatment of injection site pain); * Participated in another investigational drug study within 30 days * Judged by the investigator to be unsuitable for enrollment in this study for any reason
References
Publications (1)
- DERIVEDShore ND, Sieber P, Schimke L, Perzin A, Olsen S. Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer. Urol Nurs. 2013 Sep-Oct;33(5):236-44, 248. PMID 24354113