Conditions: BPH
Keywords: Benign Prostate Hyperplasia BPH PK/PD GnRH antagonist
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 52
Healthy volunteers: no

Brief summary:
This exploratory study will be conducted open label in a single investigational clinical unit. Altogether 52 patients with benign prostate hyperplasia (BPH) will be randomly assigned to receive 4 different treatments with degarelix.

Detailed description:
The present study aims at exploring the potential of the currently available formulation of degarelix to treat BPH with only a short transient lowering of the serum testosterone concentration to or below the castration level defined as 0.5 ng/mL. Two doses and two dosing regimens (32 and 64 mg administered either as a single administration or as two administrations separated by 14 days) will be evaluated for 42 days.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix intervention 4: Degarelix
Intervention descriptions: intervention 1: Two doses of 16 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 2: One dose of 32 mg administered as a single administration will be evaluated for 42 days. intervention 3: Two doses of 32 mg each administered as two administrations (separated by 14 days) will be evaluated for 42 days. intervention 4: One dose of 64 mg administered as a single administration will be evaluated for 42 days.

Protocol document: