Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01161563
First received: July 9, 2010
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Triptorelin pamoate
Drug: Leuprolide acetate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Randomized Crossover Trial to Assess the Tolerability of GnRH Analogue Administration in Patients With Advanced Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:
  • Patient Bother From Injection Site Burning and/or Stinging [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    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:
  • Discomfort From Injection [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection


Enrollment: 118
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161563

Locations
United States, Alabama
Watson Investigational Site
Homewood, Alabama, United States
United States, Florida
Watson Investigational Site
Daytona Beach, Florida, United States
Watson Investigational Site
Orange City, Florida, United States
United States, Idaho
Watson Investigational Site
Coeur D'Alene, Idaho, United States
United States, Indiana
Watson Investigational Site
Carmel, Indiana, United States
Watson Investigational Site
Jeffersonville, Indiana, United States
United States, Louisiana
Watson Investigational Site
Shreveport, Louisiana, United States
United States, Nevada
Watson Investigational Site
Las Vegas, Nevada, United States
United States, New Jersey
Watson Investigational Site
Mt Laurel, New Jersey, United States
Watson Investigational Site
Voorhees, New Jersey, United States
United States, New York
Watson Investigational Site
Albany, New York, United States
Watson Investigational Site
Syracuse, New York, United States
United States, Pennsylvania
Watson Investigational Site
Lancaster, Pennsylvania, United States
United States, South Carolina
Watson Investigational Site
Myrtle Beach, South Carolina, United States
United States, Texas
Watson Investigational Site
Dallas, Texas, United States
United States, Virginia
Watson Investigational Site
Norfolk, Virginia, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
Study Director: Marilyn McIlwain, BS Watson Pharmaceuticals, Inc.
  More Information

No publications provided by Watson Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01161563     History of Changes
Other Study ID Numbers: TRE1001
Study First Received: July 9, 2010
Results First Received: June 10, 2013
Last Updated: September 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Watson Pharmaceuticals:
palliative treatment
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Leuprolide
Triptorelin Pamoate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Contraceptive Agents
Contraceptive Agents, Female
Fertility Agents
Fertility Agents, Female
Luteolytic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014