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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161563
• Other study ID #: TRE1001
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2010
• Last updated: September 5, 2013
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2013
• Source: Watson Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Triptorelin pamoate
Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock
• Leuprolide acetate
Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Locations

Country	Name	City	State
United States	Watson Investigational Site	Albany	New York
United States	Watson Investigational Site	Carmel	Indiana
United States	Watson Investigational Site	Coeur D'Alene	Idaho
United States	Watson Investigational Site	Dallas	Texas
United States	Watson Investigational Site	Daytona Beach	Florida
United States	Watson Investigational Site	Homewood	Alabama
United States	Watson Investigational Site	Jeffersonville	Indiana
United States	Watson Investigational Site	Lancaster	Pennsylvania
United States	Watson Investigational Site	Las Vegas	Nevada
United States	Watson Investigational Site	Mt Laurel	New Jersey
United States	Watson Investigational Site	Myrtle Beach	South Carolina
United States	Watson Investigational Site	Norfolk	Virginia
United States	Watson Investigational Site	Orange City	Florida
United States	Watson Investigational Site	Shreveport	Louisiana
United States	Watson Investigational Site	Syracuse	New York
United States	Watson Investigational Site	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Watson Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Bother From Injection Site Burning and/or Stinging	Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection	15 minutes	No
Secondary	Discomfort From Injection	Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection	15 minutes	No