Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration

Phase 4

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Leuprolide acetate; Drug: Triptorelin pamoate

• Registration Number: NCT01161563
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

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.

Detailed Description

GnRH is given as an injection. Injections of GnRH can be uncomfortable, causing a feeling of burning or stinging. The uncomfortable feeling may be caused by differences in the types of GnRH and the site of the injection (under the skin of the abdomen, or into the muscle of the buttock or thigh).

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2013-06-10
• Status Verified: 2013-09
• Results First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Results First Posted: 2013-09-06
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Leuprolide acetate	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.
Triptorelin pamoate	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 Outcome Measures

Name	Time	Method
Patient Bother From Injection Site Burning and/or Stinging	15 minutes	Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

Secondary Outcome Measures

Name	Time	Method
Discomfort From Injection	15 minutes	Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

Trial Locations

Locations (1)

Watson Investigational Site; 🇺🇸 Norfolk, Virginia, United States