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

September 5, 2013 updated by: Watson Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Bother From Injection Site Burning and/or Stinging
Time Frame: 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
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discomfort From Injection
Time Frame: 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
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Marilyn McIlwain, BS, Watson Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

July 12, 2010

First Posted (Estimate)

July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

September 6, 2013

Last Update Submitted That Met QC Criteria

September 5, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRE1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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