Primary outcomeMean· 15 minutes
Patient Bother From Injection Site Burning and/or Stinging
| Group | Value (units on a scale) |
|---|---|
| Leuprolide Acetate | 23.87 |
| Triptorelin Pamoate | 5.84 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataRandomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
NCTNCT01161563 (opens ClinicalTrials.gov in a new tab)Other idTRE1001
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 118 participants (actual)
- Sponsor
- Watson Pharmaceuticals · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Jul 2010
- Primary completion
- Apr 2011
- Completion
- Apr 2011
- First posted
- 13 Jul 2010 (estimated)
- Last update posted
- 6 Sept 2013 (estimated)
- Conditions
- Prostate Cancer
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012
- Ph 4
Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
NCT01161563Jul 2010 to Apr 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.
Interventions
- Triptorelin pamoateDrug
- Leuprolide acetateDrug
Arms2
Active comparator
Leuprolide acetate
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.
Active comparator
Triptorelin pamoate
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Patient Bother From Injection Site Burning and/or Stinging
Time frame · 15 minutes
Registry description
Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
Secondary outcomes(1)
Discomfort From Injection
Time frame · 15 minutes
Registry description
Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· 15 minutes
Discomfort From Injection
| Group | Value (units on a scale) |
|---|---|
| Leuprolide Acetate | 20.53 |
| Triptorelin Pamoate | 5.88 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Leuprolide Acetate | – | 0 / 118 | 0 / 118 |
| Triptorelin Pamoate | – | 0 / 118 | 0 / 118 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
0 studies on this page
Indexing hint: Randomized controlled trial · 2013
Comparison of tolerability and adverse events following treatment with two GnRH agonists in patients with advanced prostate cancer.
Shore et al. 2013Urologic nursingcited by 4
PMID 24354113DOI 10.7257/1053-816x.2013.33.5.236PUB-24354113
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- Male
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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
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