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)
NCT ID: NCT00651807
Last Updated: 2022-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
16 participants
INTERVENTIONAL
2008-03-31
2008-08-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
etonogestrel
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
Arm 2
Placebo
Placebo
Every day one tablet up to 8 weeks
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
MALE
No
Sponsors
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Organon and Co
INDUSTRY
Responsible Party
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References
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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. doi: 10.1016/j.eururo.2004.07.016.
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. doi: 10.1007/s11934-003-0084-1. No abstract available.
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.
Other Identifiers
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304001
Identifier Type: -
Identifier Source: secondary_id
P05806
Identifier Type: -
Identifier Source: org_study_id
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