A Study in Men With Benign Prostatic Hyperplasia
A Study in Men With Benign Prostatic Hyperplasia
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic
 Hyperplasia (BPH)
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 -  Have completed or withdrawn from this study or have completed or withdrawn from any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.