A Trial to Investigate the Effectiveness and Safety of Org 3236 (Etonogestrel) Tablets in Men With Urinary Complaints Suggestive of a Benign Enlargement of the Prostate (304001)(P05806)

Benign Prostatic Hyperplasia (BPH) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00651807
• Other study ID #: P05806
• Secondary ID: 304001
• Status: Terminated
• Phase: Phase 2
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted to evaluate the effect of etonogestrel in comparison to placebo on: - the prostate volume and the urinary complaints; - the urinary flow and the urinary volume in the bladder after voiding; - the progression of the disease; - the sexual function, well-being and urinary complaints-related Quality of Life. In addition the safety and the way the drug is absorbed and excreted by the body will be analyzed.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• A post void residual volume >250 mL
• Use of drugs interfering with efficacy assessments within two weeks or six months prior to start treatment (depending on drug)
• Acute urinary retention within the past 12 months
• History of surgery for BPH, including other minimally invasive procedures
• Presence of urinary tract infection
• Presence or history of (subclinical) prostate cancer, bladder cancer, urethral stricture, or pelvic irradiation
• Cardiac or cerebrovascular event within the past six months
• Presence or history of any neurological disease associated with primary bladder dysfunction
• Presence or history of liver/renal disease or disturbance of liver/renal function that failed to return to normal
• Clinically relevant abnormal laboratory result as judged by the (sub)investigator

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• etonogestrel
Lowest dose of Org 3236 per two days, lowest dose of Org 3236 per day, highest dose of Org 3236 per day for 8 weeks
• Placebo
Every day one tablet up to 8 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (3)

Gonzalez CM, McVary KT. The role of combination therapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Curr Urol Rep. 2003 Aug;4(4):276-81. Review. — View Citation

Madersbacher S, Alivizatos G, Nordling J, Sanz CR, Emberton M, de la Rosette JJ. EAU 2004 guidelines on assessment, therapy and follow-up of men with lower urinary tract symptoms suggestive of benign prostatic obstruction (BPH guidelines). Eur Urol. 2004 Nov;46(5):547-54. — View Citation

McConnell J, Abrams P, Denis L, Khoury S, Roehrborn C (eds). Male Lower Urinary Tract Dysfunction - Evaluation and Management. Edition 2006 Paris, France: Editions 21, ISBN 0-9546956-6-6.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of Org 3236 on prostate volume compared to placebo		Screening (days -30 to -1), weeks 8, 12 and 24
Primary	The effect of Org 3236 on LUTS compared to placebo		Screening up to and including week 24
Primary	The effect of Org 3236 on urinary flow and postvoid residual volume compared to placebo		Screening and weeks 2 - 24
Primary	The effect on progression of LUTS		Screening up to and including week 24
Primary	The effect of Org 3236 on sexual function; well-being and LUTS-related Quality of Life compared to placebo		Screening and weeks 4 - 24; screening and weeks 2 - 24, respectively
Primary	The safety of Org 3236		Screening up to and including week 24
Primary	The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH, FSH, E2, SHBG) properties		Randomization and weeks 2 - 8; randomization and weeks 2 - 12 and 24, respectively