A Study in Men With Benign Prostatic Hyperplasia

Lilly

Status and phase: Terminated; Phase 2

Conditions: Benign Prostatic Hyperplasia

Treatments: Drug: Placebo; Drug: LY500307

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097707

10373

I1A-MC-BPAE (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 414 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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414 participants in 5 patient groups, including a placebo group

1mg LY500307

Experimental group

Treatment:

Drug: LY500307

3mg LY500307

Experimental group

Treatment:

Drug: LY500307

10mg LY500307

Experimental group

Treatment:

Drug: LY500307

25mg LY500307

Experimental group

Treatment:

Drug: LY500307

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo