Clinical trial NCT00962390: Efficacy and Safety of S-Equol on Men With Benign Prostatic Hyperplasia
Official title: Randomized, Double Blind, Multicenter, Placebo Controlled, Proof of Concept Trial to Assess the Efficacy and Safety of 4 Weeks Treatment With AUS 131 (S Equol) on Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Ausio Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 116
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of S-equol in men with benign prostatic hyperplasia.

Detailed description: The study is a phase 2a, randomized, double blind, multicenter, placebo controlled, parallel group, proof of concept study comparing the efficacy, safety, and acceptability of S-equol to placebo in patients with benign prostatic hyperplasia. The study objective is to examine a dose response of 3 dose levels of S equol versus placebo on prostate specific antigen concentrations in patients with benign prostatic hyperplasia. The safety of S-equol will be evaluated during the study.

Eligibility criteria: Inclusion Criteria:

* Is male \> 50 years of age at Screening.
* Has a normal digital rectal exam with the exception of prostate enlargement.
* Has suffered from symptoms of BPH for at least the 6 months before Screening.
* Has a prostate volume ≥ 20 mL and ≤ 70 mL as assessed by ultrasound.
* Has a serum PSA concentration \> 1.5 ng/mL and ≤ 10 ng/mL at Screening.
* Has an IPSS \> 13 at Screening and Baseline.
* Has a Qmax \> 5 cc/sec and \< 15 cc/sec with a voided volume ≥ 125 cc at Screening (and Baseline, if applicable).

Exclusion Criteria:

* Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug.
* Neurogenic bladder dysfunction.
* Has bladder neck contracture or urethral stricture.
* Has acute or chronic prostatitis or urinary tract infection.
* Has, or has a history of, prostate cancer or carcinoma of the prostate suspected on digital rectal exam or transrectal ultrasound, or has a serum PSA concentration \> 10 ng/mL; patients with a PSA concentration \> 4 ng/mL and ≤ 10 ng/mL must have prostate cancer ruled out to the satisfaction of the investigator.
* Has a residual void volume \> 250 mL.
* Has any clinically significant unstable condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
* Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma).
* Has a history of smoking more than 5 cigarettes daily within the year before Screening.
* Has resting systolic blood pressure (BP) \> 160 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg or \< 60 mmHg at Screening.
* Has bladder stones as detected by ultrasound.
* Has hematuria of unknown etiology.
* Had previous prostate surgery or other invasive treatment for BPH.
* Had prior radiation to the pelvis.
* Has Parkinson's disease or multiple sclerosis.
* Had stroke or myocardial infarction within 5 months before Baseline.
* Has abnormal screening electrocardiogram (ECG) or unstable angina or severe congestive heart failure.
* Has active liver disease renal insufficiency with creatinine \> 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count.
* Has a history of postural hypotension or has a fall in systolic BP \> 20 mm Hg after 2 minutes in a standing position.
* Received alpha blocker therapy within 28 days before Baseline.
* Received androgens, anti androgens, 5 alpha reductase inhibitors, or luteinizing hormone releasing hormone (LHRH) analogs within 3 months before Baseline.
* Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline.
* Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline.
* Has initiated new use (i.e., within the past 4 weeks before Screening) or otherwise are not on stable doses of phosphodiesterase 5 inhibitors during the 4 weeks before Screening.
* Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years.
* Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Clinical Investigator's Brochure for AUS 131 \[S equol\]), to be an unsuitable candidate to receive the study drug.
* Has tested positive on the urine drug screen.

Primary outcomes:
measure: Change From Baseline at Week 4 in Prostate Specific Antigen (PSA) Concentration.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Prostate Volume From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in Qmax From Baseline at Week 4
timeFrame: 4 weeks
measure: Categorical Change in Qmax From Baseline at Week 4
timeFrame: 4 weeks
measure: Percent Change in Qmax From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in Void Volume From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in Post-Void Residual Volume From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in in Dihydrotestosterone Concentration From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in Luteinizing Hormone Concentration From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in Total Testosterone Concentration From Baseline at Week 4
timeFrame: 4 weeks
measure: Participants Assessment of Nocturia at Week 4
timeFrame: 4 weeks
measure: Investigators Assessment of Nocturia at Week 4
timeFrame: 4 weeks
measure: Change in I-PSS Total Score From Baseline at Week 4
timeFrame: 4 weeks
measure: Change in DAN Prostate Symptom Scale From Baseline at Week 4
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: West Jordon
country: United States
facility: Advanced Clinical Research
state: Utah
city: Norfolk
country: United States
facility: Clinical Research Associates of Tidewater
state: Virginia
city: Ahmedabad
country: India
facility: Samved Hospital
city: Bangalore
country: India
facility: M S Ramaiah Memorial Hospital
city: Bangalore
country: India
facility: St. John's Medical College Hospital
city: Delhi
country: India
facility: G S Medical College and KEM Hospital
city: Delhi
country: India
facility: Indraprastha Apollo Hospital
city: Delhi
country: India
facility: V M Medical College and Safdarjung Hospital
city: Jaipur
country: India
facility: SMS Hospital
city: Mangalore
country: India
facility: A J Hospital and Research Center
city: Pune
country: India
facility: Inamdar Multispecialty Hospital
city: Pune
country: India
facility: Ruby Hall Clinic
Study officials:
affiliation: Tampa Bay Medical Research
name: Donald Bergner, MD
role: PRINCIPAL_INVESTIGATOR
References: