Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)

The objectives of the study are to develop a safe and tolerable intermittent dosage regimen
of cetrorelix pamoate that provides prolonged improvement in BPH-related signs and symptoms.

Patients will enter a 4-week run-in no-treatment observation period to confirm severity and
stability of voiding symptoms based on the International Prostate Symptom Score (IPSS).

Patients will then be allocated to study drug in a double-blind, randomized, double-dummy,
placebo-controlled fashion.

Patients will be administered an IM injection of study drug at Week 0, 2, 26 and 28 and will
be followed up to Week 52.

Then, in an open label fashion, patients will be administered an IM injection of study drug
at Week 52, 54, 78 and 80 and will be followed up to Week 90.

Inclusion Criteria:

- Benign Prostatic Hyperplasia, based on medical history

- Voiding symptoms

Exclusion Criteria:

- Urgent need for prostate surgery or prior surgical treatment of the prostate or
bladder

- Major organ dysfunction

- Eczema (atopic dermatitis) treated during the last 6 months

- Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or
botulinum toxin type a (Botox) within the last 6 months prior randomization or with α
blockers or saw palmetto within the last 6 weeks prior to randomization

- Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus
or documented neurologic disorder, urethral stricture disease or history of pelvic
radiation therapy

- History of acute obstructive, infectious, or neurological disorders of the
genitourinary tract within the last 3 months