Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
1 other identifier
interventional
118
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 prostate-cancer
Started Jul 2010
Shorter than P25 for phase_4 prostate-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 9, 2010
CompletedFirst Posted
Study publicly available on registry
July 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
September 6, 2013
CompletedSeptember 6, 2013
September 1, 2013
9 months
July 9, 2010
June 10, 2013
September 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Discomfort From Injection
15 minutes
Study Arms (2)
Leuprolide acetate
ACTIVE COMPARATORPolymeric 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.
Triptorelin pamoate
ACTIVE COMPARATORTriptorelin 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.
Interventions
Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock
Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Watson Investigational Site
Homewood, Alabama, United States
Watson Investigational Site
Daytona Beach, Florida, United States
Watson Investigational Site
Orange City, Florida, United States
Watson Investigational Site
Coeur d'Alene, Idaho, United States
Watson Investigational Site
Carmel, Indiana, United States
Watson Investigational Site
Jeffersonville, Indiana, United States
Watson Investigational Site
Shreveport, Louisiana, United States
Watson Investigational Site
Las Vegas, Nevada, United States
Watson Investigational Site
Mount Laurel, New Jersey, United States
Watson Investigational Site
Voorhees Township, New Jersey, United States
Watson Investigational Site
Albany, New York, United States
Watson Investigational Site
Syracuse, New York, United States
Watson Investigational Site
Lancaster, Pennsylvania, United States
Watson Investigational Site
Myrtle Beach, South Carolina, United States
Watson Investigational Site
Dallas, Texas, United States
Watson Investigational Site
Norfolk, Virginia, United States
Related Publications (1)
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.
PMID: 24354113DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
- Organization
- Watson Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
Marilyn McIlwain, BS
Watson Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2010
First Posted
July 13, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
September 6, 2013
Results First Posted
September 6, 2013
Record last verified: 2013-09