A Study in Men With Benign Prostatic Hyperplasia

This study has been terminated.
(Terminated due to insufficient efficacy)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01097707
First received: March 31, 2010
Last updated: February 10, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Benign Prostatic Hyperplasia
Drug: LY500307
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 24 week endpoint in International Prostate Symptom Score (IPSS) total score [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 24 week endpoint in Total Prostate Volume (TPV) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 weeks endpoint in Peak Urinary Flow Rate (Qmax) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in International Prostate Symptom Score-Quality of Life Index (IPSS-QoL) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in International Prostate Symptom Score storage, voiding and nocturia subscores [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in Prostate Specific Antigen (PSA) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting total testosterone [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28-32 weeks ] [ Designated as safety issue: Yes ]
  • Change in Lipid Profile [ Time Frame: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 28-32 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 414
Study Start Date: April 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Present at screening with a history of BPH for >6 months.
  • Have an IPSS greater than or equal to 13 at screening.
  • Have a Total Prostate Volume by Transrectal ultrasound greater than or equal to 30 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 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 PSA greater than or equal to 1.4 and less than or equal to 10 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 ng/dL at screening.
  • If hyperlipidemic, based on history, be on stable 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 attach 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097707

  Show 70 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01097707     History of Changes
Other Study ID Numbers: 10373, I1A-MC-BPAE
Study First Received: March 31, 2010
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Italy: Ministry of Health
Greece: Ethics Committee
Greece: National Organization of Medicines
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014