Clinical trial NCT01161563: Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
Official title: Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: palliative treatment
prostate cancer
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 118
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient Bother From Injection Site Burning and/or Stinging
timeFrame: 15 minutes
Secondary outcomes:
measure: Discomfort From Injection
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Watson Investigational Site
state: Alabama
city: Daytona Beach
country: United States
facility: Watson Investigational Site
state: Florida
city: Orange City
country: United States
facility: Watson Investigational Site
state: Florida
city: Coeur D'Alene
country: United States
facility: Watson Investigational Site
state: Idaho
city: Carmel
country: United States
facility: Watson Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Watson Investigational Site
state: Indiana
city: Shreveport
country: United States
facility: Watson Investigational Site
state: Louisiana
city: Las Vegas
country: United States
facility: Watson Investigational Site
state: Nevada
city: Mt Laurel
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Voorhees
country: United States
facility: Watson Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Watson Investigational Site
state: New York
city: Syracuse
country: United States
facility: Watson Investigational Site
state: New York
city: Lancaster
country: United States
facility: Watson Investigational Site
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Watson Investigational Site
state: South Carolina
city: Dallas
country: United States
facility: Watson Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Watson Investigational Site
state: Virginia
Study officials:
affiliation: Watson Pharmaceuticals, Inc.
name: Marilyn McIlwain, BS
role: STUDY_DIRECTOR
References:
citation: Shore 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.