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A Study in Men With Benign Prostatic Hyperplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097707
Recruitment Status : Terminated (Terminated due to insufficient efficacy)
First Posted : April 2, 2010
Results First Posted : April 8, 2019
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: LY500307 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1mg LY500307 Drug: LY500307
Administered orally, daily for 24 weeks

Experimental: 3mg LY500307 Drug: LY500307
Administered orally, daily for 24 weeks

Experimental: 10mg LY500307 Drug: LY500307
Administered orally, daily for 24 weeks

Experimental: 25mg LY500307 Drug: LY500307
Administered orally, daily for 24 weeks

Placebo Comparator: Placebo Drug: Placebo
Administered orally, daily for 24 weeks




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Percentage Change From Baseline to 24-Week Endpoint in Total Prostate Volume (TPV) [ Time Frame: 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).

  2. Change From Baseline to 24-Week Endpoint in Peak Urinary Flow Rate (Qmax) [ Time Frame: Baseline, 24 weeks ]
    Qmax is defined as the peak urine flow rate measured using standard calibrated uroflowmeter.

  3. Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL) [ Time Frame: 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.

  4. Change From Baseline to 24-Week Endpoint in International Prostate Symptom Score (IPSS) Storage, Voiding and Nocturia Subscores [ Time Frame: 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.

  5. Percentage Change From Baseline to 24-Week Endpoint in Prostate Specific Antigen (PSA) [ Time Frame: Baseline, 24 weeks ]
    The units of PSA measurement are nanograms per milliliter (ng/mL).

  6. Change From Baseline to 24-Week Endpoint in Fasting Total Testosterone [ Time Frame: Baseline, 24 weeks ]
  7. Change From Baseline to 24-Week Endpoint in Lipid Profile [ Time Frame: Baseline, 24 weeks ]
    The lipid profile consisted of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097707


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01097707    
Other Study ID Numbers: 10373
I1A-MC-BPAE ( Other Identifier: Eli Lilly and Company )
First Posted: April 2, 2010    Key Record Dates
Results First Posted: April 8, 2019
Last Update Posted: April 8, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases