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

Condition(s) targeted: Prostate Cancer

Intervention: Triptorelin pamoate (Drug); Leuprolide acetate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Watson Pharmaceuticals

Official(s) and/or principal investigator(s):
Marilyn McIlwain, BS, Study Director, Affiliation: Watson Pharmaceuticals, Inc.

Overall contact:
Naomi V. Dahl, Pharm. D., Phone: 973-355-8343, Email: naomi.dahl@watson.com

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.

Official title: Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Patient bother from injection site burning and/or stinging

Secondary outcome: Other patient perceptions relative to the injection

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Naomi V. Dahl, Pharm. D., Phone: 973-355-8343, Email: naomi.dahl@watson.com

Watson Investigational Site, Homewood, Alabama, United States; Recruiting

Watson Investigational Site, Daytona Beach, Florida, United States; Recruiting

Watson Investigational Site, Orange City, Florida, United States; Recruiting

Watson Investigational Site, Coeur D'Alene, Idaho, United States; Recruiting

Watson Investigational Site, Shreveport, Louisiana, United States; Not yet recruiting

Watson Investigational Site, Las Vegas, Nevada, United States; Recruiting

Watson Investigational Site, Mt Laurel, New Jersey, United States; Recruiting

Watson Investigational Site, Voorhees, New Jersey, United States; Not yet recruiting

Watson Investigational Site, Syracuse, New York, United States; Recruiting

Watson Investigational Site, Lancaster, Pennsylvania, United States; Not yet recruiting

Watson Investigational Site, Myrtle Beach, South Carolina, United States; Recruiting

Watson Investigational Site, Dallas, Texas, United States; Not yet recruiting

Watson Investigational Site, Norfolk, Virginia, United States; Recruiting

Starting date: July 2010
Last updated: August 20, 2010