A Study in Men With Benign Prostatic Hyperplasia

Phase 2

Terminated

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Drug: LY500307; Drug: Placebo

• Registration Number: NCT01097707
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study Start: 2010-04
• Study First Posted: 2010-04-02
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2012-02-10
• Disposition First Submitted QC: 2012-02-10
• Disposition First Posted: 2012-02-14
• Status Verified: 2019-03
• Results First Submitted: 2019-03-11
• Results First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Results First Posted: 2019-04-08
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 414

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1mg LY500307	LY500307	-
3mg LY500307	LY500307	-
10mg LY500307	LY500307	-
25mg LY500307	LY500307	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score	Baseline, 24 weeks	IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) with an IPSS Total Score range of 0-35 points. Higher numerical scores from the IPSS questionnaire represent greater severity of symptoms.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)	Baseline, 24 weeks	The TPV measurement (milliliters) by transrectal ultrasound (TRUS) is an established diagnostic test for men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)	Baseline, 24 weeks	IPSS QoL assesses participant's response to the following question: "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Response options are Delighted (0), Pleased (1); Mostly satisfied (2); Mixed-about equally satisfied and dissatisfied (3); Mostly dissatisfied (4); Unhappy (5); Terrible (6), with a total range of 0-6.
Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)	Baseline, 24 weeks	Qmax is defined as the peak urine flow rate measured using standard calibrated uroflowmeter.
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores	Baseline, 24 weeks	IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores range from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with a total subscore of the 3 questions for irritative subscore ranging from 0 to 15. IPSS Voiding (Obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores range from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with a total subscore of the 4 questions of the obstructive score ranging from 0 to 20. Nocturia Subscore is IPSS Question 7, which assesses how many times over the last month a participant gets up to urinate from the time they went to bed at night until the time they got up in the morning. Scores range from 0=None; 1=1 time; 2= 2 times; 3=3 times; 4=4 times; 5=5 or more times.
Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)	Baseline, 24 weeks	The units of PSA measurement are nanograms per milliliter (ng/mL).
Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone	Baseline, 24 weeks
Change From Baseline to 24-Week Endpoint in Lipid Profile	Baseline, 24 weeks	The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇷🇺 Saint Petersburg, Russian Federation