A Study in Men With Benign Prostatic Hyperplasia

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

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• Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307.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.