A phase II, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Org 3236 tablets in men with Lower Urinary Tract Symptoms (LUTS) suggestive of Benign Prostatic Hyperplasia (BPH)

Phase 1

Conditions: Benign prostatic hyperplasia
MedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasia

Registration Number: EUCTR2007-005793-31-PL

Lead Sponsor: V Organon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 240

Inclusion Criteria

1. Signed written informed consent, obtained before screening evaluations;
2. Men diagnosed with LUTS suggestive of BPH:
2.1. Baseline IPSS score of = 12 (moderate to severe);
2.2. Prostate volume of = 40 mL and < 100 mL (based on TRUS);
2.3. Peak urinary flow rate = 15 mL/s with a voided volume of = 125 mL;
3. Age at least 50 but not older than 80 years at screening;
4. PSA < 10 ng/mL and exclusion of prostate cancer to the satisfaction of the investigator (e.g. by biopsy).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

5. A postvoid residual volume >250 mL;
6. Use of anti-androgens, androgens, Gonadotropin Releasing Hormone (GnRH) antagonists, or 5a-reductase inhibitors within six months prior to start trial medication;
7. Use of a-blockers, phytotherapy (for LUTS) or drugs interfering with bladder function within two weeks prior to start trial medication;
8. Presence of hypogonadism as judged by the (sub)investigator;
9. Acute urinary retention within the past 12 months;
10. History of surgery for BPH, including other minimally invasive procedures;
11. Presence of urinary tract infection;
12. Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation;
13. Presence or history (within the past 12 months) of depression or other psychiatric disease of moderate or severe intensity;
14. Cardiac or cerebrovascular event within the past six months;
15. Presence or history of any neurological disease associated with primary bladder dysfunction;
16. Presence or history of liver disease or disturbance of liver function that failed to return to normal;
17. Presence or history of renal disease or disturbance of renal function that failed to return to normal;
18. Present use or use within two months prior to screening of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, hydantoins, rifampicin, ritonavir, nelfinavir, and griseofulvin;
19. Presence or history (within the past 12 months) of alcohol or drug abuse as judged by the (sub)investigator;
20. Clinically relevant abnormal laboratory result as judged by the (sub)investigator;
21. Known hypersensitivity to any of the components of trial medication;
22. Administration of investigational drugs and/or participation in another clinical trial within two months prior to screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • The effect of Org 3236 on prostate volume compared to placebo;<br>• The effect of Org 3236 on LUTS compared to placebo;<br>• The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo;<br>• The effect on progression of LUTS;<br>• The effect of Org 3236 on sexual function, well-being and LUTS-related Quality of Life compared to placebo;<br>• The safety of Org 3236;<br>• The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties.<br>;Secondary Objective: ;Primary end point(s): -Prostate volume<br>-Effect on lower urinary tract symptoms<br>-Urinary flow rate<br>-Postvoid residual volume<br>-Progression of lower urinary tract symptoms<br>-Sexual functioning, well-being and Quality of life<br>-Pharmacokinetics and pharmacodynamics of Org 3236<br>-Safety of Org 3236<br>

Secondary Outcome Measures

Name	Time	Method

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