CTRI/2012/05/002683Other2 期
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Proof-of-Concept Trialto Assess the Efficacy and Safety of 4-Weeks Treatment with AUS-131 (S-Equol) on Benign Prostatic Hyperplasia - AUS-CT04
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria
- •A patient will be eligible for study entry if all of the following inclusion criteria are
- •1. Is male > 50 and <=70 years of age at Screening.
- •2. Has a normal digital rectal exam with the exception of prostate enlargement.
- •3. Has suffered from symptoms of BPH for at least the 6 months before Screening (e.g., micturition disturbances such as daytime frequency, nocturia, urgency, difficulty initiating micturition, impaired quality of the urinary stream, feeling of incomplete voiding, or interruption of the urinary stream).
- •4. Has a prostate volume >= 20 mL and <= 70 mL as assessed by ultrasound.
- •5. Has a serum PSA concentration > 1.5 ng/mL and <= 10 ng/mL at Screening.
- •6. Has an IPSS >= 13 at Screening and Baseline.
- •7. Has a Qmax > 5 cc/sec and < 15 cc/sec with a voided volume >= 125 cc at Screening (and Baseline, if applicable).
- •8. Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements.
- •9. Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) before the conduct of any study procedure.
- •10. Is willing and able to comply with all study requirements and instructions of the site study staff.
排除标准
- •Exclusion Criteria
- •A patient will not be eligible for study entry if any of the following exclusion criteria are met:
- •1. Has a known history of allergic reaction or clinically significant intolerance to ingredients of the study drug.
- •2. Neurogenic bladder dysfunction.
- •3. Has bladder neck contracture or urethral stricture.
- •4. Has acute or chronic prostatitis or urinary tract infection.
- •5. 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.
- •6. Has a residual void volume > 250 mL.
- •7. Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, hepatic, renal, endocrine, or gastric disease or any other condition that, in the opinion of the investigator, could compromise the patientâ??s welfare, ability to communicate with the study staff, or otherwise
- •contraindicate study participation.
- •8. Shows presence of any manifest premalignant or malignant disease except treated skin cancers (except melanoma).
- •9. Has a history of smoking more than 5 cigarettes daily within the year before
- •10. Has resting systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic
- •BP > 90 mmHg or < 60 mmHg at Screening.
- •11. Has bladder stones as detected by ultrasound.
- •12. Has hematuria of unknown etiology.
- •13. Had previous prostate surgery or other invasive treatment for BPH.
- •14. Had prior radiation to the pelvis.
- •15. Has Parkinsonâ??s disease or multiple sclerosis.
- •16. Had stroke or myocardial infarction within 5 months before Baseline.
- •17. Has clinically significant abnormal screening electrocardiogram (ECG) or unstable
- •angina or severe congestive heart failure.
- •18. Has active liver disease with aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN), alanine aminotransferase (ALT) > 2 times ULN, unexplained alkaline phosphatase > 3 times ULN, total bilirubin > ULN, renal insufficiency with creatinine > 1.7 mg/dL, or clinically significant abnormal hemoglobin, white blood cell count, or platelet count.
- •19. Has a history of postural hypotension or has a fall in systolic BP > 20 mm Hg after 2 minutes in a standing position.
- •20. Received alpha blocker therapy within 28 days before Baseline.
- •21. Received androgens, anti-androgens, 5-alpha reductase inhibitors, or luteinizing hormone-releasing hormone (LHRH) analogs within 3 months before Baseline.
- •22. Received tricyclic antidepressants or plant extracts (e.g., saw palmetto) within 1 month before Baseline.
- •23. Received sedating antihistamines, sympathomimetics, or anticholinergics within 1 week before Baseline.
- •24. 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.
- •25. Has known or suspected history of alcoholism or drug abuse or misuse within the last 5 years.
- •26. Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current versi
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