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A Study in Men With Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostatic Hyperplasia

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

LY500307

Placebo

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept 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Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY500307.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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

1mg LY500307

3mg LY500307

10mg LY500307

25mg LY500307

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

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

Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)

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 Peak Urinary Flow Rate (Qmax)

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-Quality of Life Index (IPSS-QoL)

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 International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores

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)

The units of PSA measurement are nanograms per milliliter (ng/mL).

Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone

Change From Baseline to 24-Week Endpoint in Lipid Profile

The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.

Full Information

NCT ID

NCT01097707

First Posted

March 31, 2010

Last Updated

March 11, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01097707

Brief Title

A Study in Men With Benign Prostatic Hyperplasia

Official Title

A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 Weeks in Men With Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to insufficient efficacy

Study Start Date

April 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

414 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1mg LY500307

Arm Type

Experimental

Arm Title

3mg LY500307

Arm Type

Experimental

Arm Title

10mg LY500307

Arm Type

Experimental

Arm Title

25mg LY500307

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

LY500307

Intervention Description

Administered orally, daily for 24 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally, daily for 24 weeks

Primary Outcome Measure Information:

Title

Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score

Description

Time Frame

Baseline, 24 weeks

Secondary Outcome Measure Information:

Title

Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)

Description

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).

Time Frame

Baseline, 24 weeks

Title

Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)

Description

Qmax is defined as the peak urine flow rate measured using standard calibrated uroflowmeter.

Time Frame

Baseline, 24 weeks

Title

Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)

Description

Time Frame

Baseline, 24 weeks

Title

Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores

Description

Time Frame

Baseline, 24 weeks

Title

Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)

Description

The units of PSA measurement are nanograms per milliliter (ng/mL).

Time Frame

Baseline, 24 weeks

Title

Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone

Time Frame

Baseline, 24 weeks

Title

Change From Baseline to 24-Week Endpoint in Lipid Profile

Description

The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.

Time Frame

Baseline, 24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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: Finasteride or dutasteride for at least 6 months prior to screening. Any alpha-adrenergic antagonists for at least 4 weeks prior to screening. Any other non-experimental BPH therapy (including an herbal preparation) for at least 4 weeks prior to screening. Any other experimental or off-label BPH therapy such as injectable therapies with a protracted effect for at least 6 months prior to screening. Any overactive bladder treatment for at least 4 weeks prior to screening. 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: Recent Myocardial infarction, unstable angina, stroke or Transient ischemic attack within 6 months of screening. Recent coronary intervention that includes coronary artery bypass surgery, percutaneous coronary artery intervention, or stent placement within 6 months of screening. Recent history of positive stress tests without any written documentation of effective intervention within 6 months of screening. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

City

Anchorage

State/Province

Alaska

ZIP/Postal Code

99508

Country

United States

Facility Name

City

Glendora

State/Province

California

ZIP/Postal Code

91741

Country

United States

Facility Name

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

City

San Bernardino

State/Province

California

ZIP/Postal Code

92404

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80210

Country

United States

Facility Name

City

Parker

State/Province

Colorado

ZIP/Postal Code

80134

Country

United States

Facility Name

City

Middlebury

State/Province

Connecticut

ZIP/Postal Code

06762

Country

United States

Facility Name

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

Facility Name

City

Coral Springs

State/Province

Florida

ZIP/Postal Code

33065

Country

United States

Facility Name

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46825

Country

United States

Facility Name

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67708

Country

United States

Facility Name

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

City

Greenbelt

State/Province

Maryland

ZIP/Postal Code

20770

Country

United States

Facility Name

City

Troy

State/Province

Michigan

ZIP/Postal Code

48084

Country

United States

Facility Name

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

City

Garden City

State/Province

New York

ZIP/Postal Code

11530

Country

United States

Facility Name

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45212

Country

United States

Facility Name

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43220

Country

United States

Facility Name

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

City

Bala-Cynwyd

State/Province

Pennsylvania

ZIP/Postal Code

19004

Country

United States

Facility Name

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

City

Arlington

State/Province

Texas

ZIP/Postal Code

76017

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Seattle

State/Province

Washington

ZIP/Postal Code

98166

Country

United States

Facility Name

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Bentleigh East

State/Province

Victoria

ZIP/Postal Code

3165

Country

Australia

Facility Name

City

Mentone

State/Province

Victoria

ZIP/Postal Code

3194

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3N1

Country

Canada

Facility Name

City

St. John

State/Province

New Brunswick

ZIP/Postal Code

E2L 3J8

Country

Canada

Facility Name

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2N 3B9

Country

Canada

Facility Name

City

Garches

ZIP/Postal Code

92380

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06002

Country

France

Facility Name

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45067

Country

France

Facility Name

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

City

Bad Bergzabern

ZIP/Postal Code

76887

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

14057

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

City

Holzminden

ZIP/Postal Code

D-37603

Country

Germany

Facility Name

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

City

Oranienburg

ZIP/Postal Code

16515

Country

Germany

Facility Name

City

Reutlingen

ZIP/Postal Code

72764

Country

Germany

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

Larissa

ZIP/Postal Code

41221

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

City

Cefala

ZIP/Postal Code

90015

Country

Italy

Facility Name

City

Firenze

ZIP/Postal Code

50012

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00161

Country

Italy

Facility Name

City

Moscow

ZIP/Postal Code

127473

Country

Russian Federation

Facility Name

City

Rostov-On-Don

ZIP/Postal Code

344011

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

196247

Country

Russian Federation

12. IPD Sharing Statement

Learn more about this trial

A Study in Men With Benign Prostatic Hyperplasia

We'll reach out to this number within 24 hrs