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

Phase 2

Terminated

• Conditions: Benign Prostatic Hyperplasia

• Registration Number: NCT00237536
• Lead Sponsor: Threshold Pharmaceuticals

Brief Summary

The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-10-10
• Study First Submitted QC: 2005-10-10
• Study First Posted: 2005-10-12
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-28
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

1. Capable of understanding the purpose and risks of the study and sign a statement of informed consent
2. Male 65-80 years of age (or 40-80 with vasectomy). Vasectomized men must have documentation of azoospermia.
3. Presence of LUTS (lower urinary tract symptoms) for at least 3 months
4. Prostate volume measured by TRUS (transrectal ultrasound) > 30 cc
5. Qmax < 15 mL/sec when measured by uroflowmetry (minimum of 125 mL must be voided)
6. IPSS (International Prostate Symptom Score) > 12
7. PSA > 1.0 ng/mL
8. Must ensure and consent to use medically acceptable methods of contraception throughout the entire study with sexual partners of childbearing potential
9. Able to comply with the prescribed treatment protocol and evaluations

Exclusion Criteria

1. Prior treatment for BPH with alpha blockers and/or herbal supplements for the treatment of BPH in the past 2 weeks (alpha-blockers and/or 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.

2. Prior surgery of the prostate (except biopsies; subject is eligible to enroll one month after full recovery from prostate biopsy.)

3. 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).

4. Active urinary tract infections (UTI)

5. Active cardiac, renal or hepatic disease as evidenced by:

   1. Serum creatinine > 1.8 mg/dL
   2. ALT or AST > 2.5x the upper limit of normal
   3. History of active myocardial infarction, unstable cardiac arrhythmias, or stroke within 6 months prior to screening
   4. Uncontrolled congestive heart failure

6. Uncontrolled diabetes mellitus (fasting blood glucose > 200 mg/dL)

7. Use of systemic steroids for any reason (systemic steroid usage is not allowed during the study). Inhaled and/or topical steroids are allowed.

8. Concurrent participation or participation in an investigational drug study within the past 30 days prior to screening

9. Concomitant disease or condition that could interfere with the conduct of the study, or would in the opinion of the Investigator, pose an unacceptable risk to the subject

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
IPSS

Secondary Outcome Measures

Name	Time	Method
Maximum urinary flow rate (Qmax)
Post-void residual urine volume (PVR)
Prostate volume
Prostate specific antigen (PSA)

Trial Locations

Locations (34)

Advanced Clinical Therapeutics; 🇺🇸 Tucson, Arizona, United States

Chris B. Threatt, MD Inc.; 🇺🇸 Atherton, California, United States

Urological Sciences Research Foundation; 🇺🇸 Culver City, California, United States

Atlantic Urological Medical Group; 🇺🇸 Long Beach, California, United States

California Professional Research; 🇺🇸 Newport Beach, California, United States

San Diego Uro-Research; 🇺🇸 San Diego, California, United States

Stanford University Hospital; 🇺🇸 Stanford, California, United States

Urology Research Options; 🇺🇸 Aurora, Colorado, United States

Connecticut Clinical Research Center Urology Specialists; 🇺🇸 Waterbury, Connecticut, United States

South Florida Medical Research; 🇺🇸 Aventura, Florida, United States

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