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Status:

TERMINATED

Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Lead Sponsor:

Threshold Pharmaceuticals

Collaborating Sponsors:

PRA Health Sciences

Conditions:

Benign Prostatic Hyperplasia

Enlarged Prostate

Eligibility:

MALE

50-80 years

Phase:

PHASE3

Brief Summary

The purpose of this study is to evaluate the efficacy of lonidamine (50mg, 150mg) compared to placebo in subjects with symptomatic BPH.

Eligibility Criteria

Inclusion

  • Capable of understanding the purpose and risks of the study and sign a statement of informed consent
  • Male 50-80 years of age
  • Presence of LUTS (lower urinary tract symptoms) for at least 3 months
  • Prostate volume measured by TRUS (transrectal ultrasound) \> 30 cc
  • Qmax \< 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided)
  • I-PSS (International prostate symptom score) \> 12
  • PSA \> 1.0 ng/mL
  • Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential
  • Able to comply with the prescribed treatment protocol and evaluations

Exclusion

  • Prior treatment for BPH with alpha-blockers and/or herbal supplements in the past 2 weeks (alpha-blockers and herbal supplements for the treatment of BPH are not allowed during the study). Prior treatment with 5-alpha-reductase inhibitors is allowed if discontinued at least 3 months prior to enrollment.
  • Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)
  • Current or past evidence of malignant disease of the prostate or prostatic intraepithelial neoplasia (for subjects with PSA between 4 - 10 ng/mL, prostate cancer must be ruled out to the satisfaction of the Principal Investigator. Subjects with PSA \>10 ng/mL are excluded.)
  • Active urinary tract infections (UTI)
  • Active cardiac, renal or hepatic disease as evidenced by:
  • Serum creatinine \> 1.8 mg/dL
  • ALT or AST \> 2.5x the upper limit of normal at screen
  • History of active myocardial infarction,unstable cardiac arrhythmias or stroke within 6 months prior to screening
  • Uncontrolled congestive heart failure
  • Uncontrolled diabetes mellitus (fasting blood glucose \> 200 mg/dL)
  • Use of systemic teriods for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.
  • Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening
  • Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the investigator,pose an unnaceptabele risk to the subject

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

End Date :

December 1 2006

Estimated Enrollment :

480 Patients enrolled

Trial Details

Trial ID

NCT00435448

Start Date

June 1 2005

End Date

December 1 2006

Last Update

April 29 2009

Active Locations (58)

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Page 1 of 15 (58 locations)

1

Vivantes Klinikum am Urban, Klinik für Urologie

Berlin, Germany, 10967

2

ClinPharm International GmbH & Co KG--Chemnitz

Chemnitz, Germany, 09120

3

Universitätsklinik Köln, Klinik und Poliklinik für Urologie

Cologne, Germany, 50924

4

ClinPharm International GmbH & Co KG--Dresden

Dresden, Germany, 01067