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)

Eli Lilly and Company1 site in 1 country414 target enrollmentApril 2010

ConditionsBenign Prostatic Hyperplasia

InterventionsLY500307 Placebo

DrugsLY500307 Placebo

Overview

Phase: Phase 2
Intervention: LY500307
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Enrollment: 414
Locations: 1
Primary Endpoint: Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Total Score
Status: Terminated
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 2010

End Date

October 2011

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

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.

Exclusion Criteria

•Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY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

Arms & Interventions

10mg LY500307

Intervention: LY500307

25mg LY500307

Intervention: LY500307

1mg LY500307

Intervention: LY500307

3mg LY500307

Intervention: LY500307

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV)(Baseline, 24 weeks)
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL)(Baseline, 24 weeks)
Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax)(Baseline, 24 weeks)
Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores(Baseline, 24 weeks)
Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA)(Baseline, 24 weeks)
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)