NCT01161563

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Watson Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Triptorelin pamoate	Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock
DRUG	Leuprolide acetate	Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-07-13
• Last updated: 2013-09-06
• Results posted: 2013-09-06

Locations

16 sites across 1 country: United States