A Study in Men With Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: LY500307; Placebo
Intervention description: Administered orally, daily for 24 weeks; Administered orally, daily for 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 414.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

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.