Conditions: Prostate Cancer
Keywords: palliative treatment prostate cancer
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 118
Healthy volunteers: no

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.

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).

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Triptorelin pamoate intervention 2: Leuprolide acetate
Intervention descriptions: intervention 1: Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock intervention 2: Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.

Protocol document: