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
Information source: Organon
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia (BPH)
Intervention: etonogestrel (Drug); etonogestrel (Drug); etonogestrel (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Organon Overall contact:
Ellen C.M. Mommers, PhD, Phone: 0031 412 663712, Email: ellen.mommers@organon.com
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.
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The effect of Org 3236 on prostate volume compared to placebo;The effect of Org 3236 on LUTS compared to placebo; The effect of Org 3236 on urinary flow and postvoid residual volume
compared to placebo; The effect on progression of LUTS; The effect of Org 3236 on sexual function; well-being and LUTS-related
Quality of Life compared to placebo; The safety of Org 3236; The pharmacokinetic (Org 3236) and pharmacodynamic (T, DHT, LH,
FSH, E2, SHBG) properties.
Detailed description:
Benign Prostate Hyperplasia (BPH) is a common disorder in the elderly male population that is
characterized by a progressive enlargement of the prostatic tissue resulting in obstruction
of the proximal urethra and causing urinary flow disturbances. Currently, pharmacological
treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia
(LUTS/BPH) mainly consists of α-adrenergic inhibitors or 5α-reductase inhibitors, but also
the combination of these inhibitors has been investigated. One single compound with fast
onset of action (faster than 5α-reductase inhibitors) and prevention of clinical progression
(reduction of prostate volume, prevention of acute urinary retention and transurethral
resection of the prostate) would be an improvement to currently available BPH therapies.
Etonogestrel (Org 3236) has been widely used in contraceptive pills for females, and has also
been tested for male contraception. Etonogestrel is known to have a decreasing effect on the
testosterone level. A lower testosterone concentration has a reductive effect on the volume
of the prostate and therefore may improve urinary complaints related to an enlarged prostate.
The current trial will be an explorative clinical trial to test the concept of etonogestrel
(Org 3236) for LUTS/BPH.
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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).
Exclusion Criteria:
5. A post void residual volume >250 mL;
6. Use of drugs interfering with efficacy assessments within two weeks or six months
prior to start treatment (depending on drug);
7. Acute urinary retention within the past 12 months;
8. History of surgery for BPH, including other minimally invasive procedures;
9. Presence of urinary tract infection;
10. Presence or history of (subclinical) prostate cancer, bladder cancer, urethral
stricture, or pelvic irradiation;
11. Cardiac or cerebrovascular event within the past six months;
12. Presence or history of any neurological disease associated with primary bladder
dysfunction;
13. Presence or history of liver/renal disease or disturbance of liver/renal function that
failed to return to normal;
14. Clinically relevant abnormal laboratory result as judged by the (sub)investigator.
Locations and Contacts
Ellen C.M. Mommers, PhD, Phone: 0031 412 663712, Email: ellen.mommers@organon.com
Centro de Diagnóstico Urológico - Av. Córdoba 2424 -, Buenos Aires C1120AAT, Argentina; Recruiting
Edgardo Becher, MD, Principal Investigator
Instituto Médico Especializado - Hidalgo 568 -, Buenos Aires 1405, Argentina; Recruiting
Armando Bechara, MD, Principal Investigator
Hospital Español - Av. Belgrano 2975 -, Buenos Aires C1209AAB, Argentina; Recruiting
Marcelo Medel, MD, Principal Investigator
Urologische Gemeinschaftspraxis - Bernauer Strasse 100 -, Oranienburg 16515, Germany; Recruiting
Detlef Quast, MD, Principal Investigator
Artztpraxis für Urologie - Bundesallee 213-214 -, Berlin 10719, Germany; Recruiting
Jürgen Herzig, MD, Principal Investigator
Universitair Medisch Centrum St. Radboud - Geert, Nijmegen 6525 GA, Netherlands; Recruiting
F.C.H. d'Áncona, PhD, Principal Investigator
Catharina Ziekenhuis - Michelangelolaan 2 -, Eindhoven 5623 EJ, Netherlands; Recruiting
H.J.E.J. Vrijhof, MD, Principal Investigator
Uroprojekt Spolka cywilna - ul. Mieszka I-go 24 -, Siedlce 08-110, Poland; Recruiting
Piotr Kania, MD, Principal Investigator
Centrum Diagnostyki Medycznej MULTI-MED - ul. Okopowa 33, Warszawa 01-059, Poland; Recruiting
Piotr Trypens, MD, Principal Investigator
Urology Research - Sheffield Teaching Hospital NHS Trust, Royal Hallamshire Hospital, Sheffield S10 2JF, United Kingdom; Recruiting
Prof. Dr. Christopher Chapple, Principal Investigator
The Royal Free Hospital - Pond Street -, London NW3 2QR, United Kingdom; Recruiting
Prof. Dr. Pierre Bouloux, Bsc. MD, FRCP, Principal Investigator
Additional Information
Related publications: 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. 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. No abstract available.
Starting date: March 2008
Ending date: May 2009
Last updated: April 23, 2008
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