Status:
TERMINATED
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)
Lead Sponsor:
Organon and Co
Conditions:
Benign Prostatic Hyperplasia (BPH)
Eligibility:
MALE
50-80 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00651807
Start Date
March 1 2008
End Date
August 1 2008
Last Update
February 4 2022
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