A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH) - BPAE

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 575

Inclusion Criteria

Male patients with a history of BPH and moderate-to-severe LUTS due to prostate enlargement, who are at least 45 years of age and who have given informed consent, are eligible to participate in this study. Eligible patients must: Have an IPSS >/=13 at the placebo lead-in visit (Visit 2). Have a TPV by TRUS >/=30 mL at Visit 2. Show signs of bladder outlet obstruction as defined by a peak urinary flow rate (Qmax) >/=4 and /=1.4 and 4 ng/mL, prostate cancer must be excluded via a documented prostate biopsy within 12 months of Visit 1 and prior to the patient s Visit 2. Demonstrate a Post Void Residual (PVR) /=300 ng/dL at screening (Visit 1). If hyperlipidemic, based on history, be on stable statin treatment as determined by the investigator for at least 2 months prior to Visit 2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from study participation if they: Have a history of BPH-related invasive procedures (for example, transurethral prostatectomy [TURP], open prostatectomy, and minimally invasive procedures that include thermal-based therapies, transurethral microwave treatment, transurethral needle ablation, and stents). Have active cardiovascular disease as evidenced by the following: oRecent myocardial infarction (MI), unstable angina, stroke, or transient ischemic attack (TIA) within 6 months of Visit 2. oRecent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of Visit 2. oRecent history of positive stress tests without any written documentation of effective intervention within 6 months of Visit 2. oEvidence of heart disease categorized as ≥Class III functional classification of New York Heart Association (NYHA) within 6 months of Visit 2. Have known or suspected history of prostate cancer, breast cancer, or other clinically significant neoplastic disease (other than squamous cell or basal cell carcinoma of skin). Have a history of deep venous thrombosis or pulmonary embolism disease. Have moderate to severe renal insufficiency (defined as an estimated glomerular filtration rate (eGFR) <50 mL/min/1.73m2 calculated from the Modification of Diet in Renal Disease [MDRD] formula [Huang et al. 2009]). Have a HbA1c >9.0%. Are on testosterone replacement therapy or on drugs that influence the hypothalamus-pituitary-gonadal axis, which may include any estrogen preparation, selective estrogen-receptor modulators (SERMs), gonadotropin releasing hormone (GnRH) agonists/antagonists, or androgen receptor antagonists within1 month prior to Visit 1. Patients on stable doses of thyroid replacement therapy will be allowed in this study. Are on pharmacological treatment other than statins for hyperlipidemia.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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