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

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ClinicalTrials.gov Identifier: NCT01161563
Recruitment Status : Completed
First Posted : July 13, 2010
Results First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Prostate Cancer
Interventions Drug: Triptorelin pamoate
Drug: Leuprolide acetate
Enrollment 118
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Triptorelin First, Then Leuprolide Acetate Leuprolide Acetate First, Then Triptorelin
Hide Arm/Group Description

Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area.

A detailed breakdown of participant flow by treatment period for each arm is not available.

Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.

A detailed breakdown of participant flow by treatment period for each arm is not available.

Period Title: Overall Study
Started 63 55
Completed 58 49
Not Completed 5 6
Arm/Group Title Leuprolide Acetate First, Then Triptorelin Triptorelin First, Then Leuprolide Acetate Total
Hide Arm/Group Description Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock. Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area. Total of all reporting groups
Overall Number of Baseline Participants 55 63 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 63 participants 118 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  21.8%
17
  27.0%
29
  24.6%
>=65 years
43
  78.2%
46
  73.0%
89
  75.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 63 participants 118 participants
75.0  (9.6) 73.2  (9.6) 74  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 63 participants 118 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
55
 100.0%
63
 100.0%
118
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 63 participants 118 participants
55 63 118
1.Primary Outcome
Title Patient Bother From Injection Site Burning and/or Stinging
Hide Description Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
Time Frame 15 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.
Arm/Group Title Leuprolide Acetate Triptorelin Pamoate
Hide Arm/Group Description:
Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
Overall Number of Participants Analyzed 107 107
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
23.87
(19.98 to 27.76)
5.84
(1.95 to 9.73)
2.Secondary Outcome
Title Discomfort From Injection
Hide Description Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection
Time Frame 15 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.
Arm/Group Title Leuprolide Acetate Triptorelin Pamoate
Hide Arm/Group Description:
Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
Overall Number of Participants Analyzed 107 107
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
20.53
(16.49 to 24.56)
5.88
(1.85 to 9.92)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Leuprolide Acetate Triptorelin Pamoate
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Leuprolide Acetate Triptorelin Pamoate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Leuprolide Acetate Triptorelin Pamoate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/118 (0.00%)   0/118 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Leuprolide Acetate Triptorelin Pamoate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/118 (0.00%)   0/118 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research
Organization: Watson Laboratories, Inc.
Phone: 801-588-6641
Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01161563     History of Changes
Other Study ID Numbers: TRE1001
First Submitted: July 9, 2010
First Posted: July 13, 2010
Results First Submitted: June 10, 2013
Results First Posted: September 6, 2013
Last Update Posted: September 6, 2013