a study in men with benign prostatic hyperplasia

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of the study is to determine whether ly500307 helps symptoms of benign prostatic hyperplasia (bph)


Eligibility criteria:
inclusion criteria: * present at screening with a history of benign prostatic hyperplasia (bph) for \>6 months. * have an international prostate symptom score (ipss) greater than or equal to 13 at screening. * have a total prostate volume by transrectal ultrasound greater than or equal to 30 milliliter (ml) at screening. * show signs of bladder outlet obstruction as defined by a peak urinary flow rate (qmax) greater than or equal to 4 and less than or equal to 15 milliliter/second (ml/sec) (from a prevoid total bladder volume \[assessed by ultrasound\] of greater than or equal to 150 to less than or equal to 550 ml and a minimum voided volume of 125 ml) at screening. * have a prostate-specific antigen (psa) greater than or equal to 1.4 and less than or equal to 10 nanogram/milliliter (ng/ml) at screening. * demonstrate a post void residual less than or equal to 300 ml by ultrasound at screening. * have not received the following treatments within the specified time period: 1. finasteride or dutasteride for at least 6 months prior to screening. 2. any alpha-adrenergic antagonists for at least 4 weeks prior to screening. 3. any other non-experimental bph therapy (including an herbal preparation) for at least 4 weeks prior to screening. 4. any other experimental or off-label bph therapy such as injectable therapies with a protracted effect for at least 6 months prior to screening. 5. any overactive bladder treatment for at least 4 weeks prior to screening. 6. any erectile dysfunction treatment which may include oral phosphodiesterase type 5 inhibitors or devices for at least 4 weeks prior to screening. * have a morning fasting total testosterone concentration greater than or equal to 300 nanogram/deciliter (ng/dl) at screening. * if hyperlipidemic, based on history, be stable on statin treatment as determined by the investigator for at least 2 months prior to screening. exclusion criteria: * have completed or withdrawn from this study or have completed or withdrawn from any other study investigating ly500307. * have any history of bph-related invasive procedures (for example, transurethral resection of the prostate, 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: 1. recent myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months of screening. 2. recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of screening. 3. recent history of positive stress tests without any written documentation of effective intervention within 6 months of screening. 4. evidence of heart disease categorized as greater than or equal to class iii functional classification of new york heart association (nyha) within 6 months of screening. * 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. * have a hemoglobin a1c (hba1c) greater than 9.0%. * are on testosterone replacement therapy, or drugs that influence the hypothalamus-pituitary-gonadal axis. * are on pharmacological treatment other than statins for hyperlipidemia.