Trial Outcomes & Findings for Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration (NCT NCT01161563)

Results Overview

Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

118 participants

Primary outcome timeframe

15 minutes

Results posted on

2013-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Triptorelin First, Then Leuprolide Acetate 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.	Leuprolide Acetate First, Then Triptorelin 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.
Overall Study STARTED	63	55
Overall Study COMPLETED	58	49
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Leuprolide Acetate First, Then Triptorelin n=55 Participants 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 First, Then Leuprolide Acetate n=63 Participants 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 n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Age Continuous	75.0 years STANDARD_DEVIATION 9.6 • n=5 Participants	73.2 years STANDARD_DEVIATION 9.6 • n=7 Participants	74 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	63 Participants n=7 Participants	118 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	63 participants n=7 Participants	118 participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Population: Per-protocol population, defined as all patients who receive both study drugs and complete both post-injection questionnaires.

Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

Outcome measures

Outcome measures
Measure	Leuprolide Acetate n=107 Participants 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.	Triptorelin Pamoate n=107 Participants 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.
Patient Bother From Injection Site Burning and/or Stinging	23.87 units on a scale Interval 19.98 to 27.76	5.84 units on a scale Interval 1.95 to 9.73

SECONDARY outcome

Timeframe: 15 minutes

Population: Per-protocol population, defined as all subjects who receive both study drugs and complete both post-injection questionnaires.

Questionnaire responses recorded on a Visual Analog Scale (VAS), which has a range of 0-100 mm, assessed approximately 15 minutes post-injection

Outcome measures

Outcome measures
Measure	Leuprolide Acetate n=107 Participants 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.	Triptorelin Pamoate n=107 Participants 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.
Discomfort From Injection	20.53 units on a scale Interval 16.49 to 24.56	5.88 units on a scale Interval 1.85 to 9.92

Adverse Events

Leuprolide Acetate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Triptorelin Pamoate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary Hoel, RPh, PhD, Vice President, Global Brand Clinical Research

Watson Laboratories, Inc.

Phone: 801-588-6641

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60