A Study in Men With Benign Prostatic Hyperplasia

Inclusion Criteria:

• Present at screening with a history of BPH for >6 months.
• Have an IPSS greater than or equal to 13 at screening.
• Have a Total Prostate Volume by Transrectal ultrasound greater than or equal to 30 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 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 PSA greater than or equal to 1.4 and less than or equal to 10 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 ng/dL at screening.
• If hyperlipidemic, based on history, be on stable 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• Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307.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 attach 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 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.