NCT01097707

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
8 countries

70 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2010

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

April 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

March 31, 2010

Results QC Date

March 11, 2019

Last Update Submit

March 11, 2019

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 24 weeks

Secondary Outcomes (7)

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

    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-Quality of Life Index (IPSS-QoL)

    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

  • +2 more secondary outcomes

Study Arms (5)

1mg LY500307

EXPERIMENTAL
Drug: LY500307

3mg LY500307

EXPERIMENTAL
Drug: LY500307

10mg LY500307

EXPERIMENTAL
Drug: LY500307

25mg LY500307

EXPERIMENTAL
Drug: LY500307

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LY500307DRUG

Administered orally, daily for 24 weeks

10mg LY5003071mg LY50030725mg LY5003073mg LY500307
PlaceboDRUG

Administered orally, daily for 24 weeks

Placebo

Eligibility Criteria

Age45 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (70)

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Huntsville, Alabama, 35801, United States

Location

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Anchorage, Alaska, 99508, United States

Location

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Glendora, California, 91741, United States

Location

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Newport Beach, California, 92660, United States

Location

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San Bernardino, California, 92404, United States

Location

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San Diego, California, 92103, United States

Location

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Tarzana, California, 91356, United States

Location

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Denver, Colorado, 80210, United States

Location

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Parker, Colorado, 80134, United States

Location

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Middlebury, Connecticut, 06762, United States

Location

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Aventura, Florida, 33180, United States

Location

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Bradenton, Florida, 34205, United States

Location

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Celebration, Florida, 34747, United States

Location

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Coral Springs, Florida, 33065, United States

Location

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Coeur d'Alene, Idaho, 83814, United States

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Meridian, Idaho, 83642, United States

Location

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Chicago, Illinois, 60611, United States

Location

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Fort Wayne, Indiana, 46825, United States

Location

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West Des Moines, Iowa, 50266, United States

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Wichita, Kansas, 67708, United States

Location

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Shreveport, Louisiana, 71106, United States

Location

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Greenbelt, Maryland, 20770, United States

Location

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Troy, Michigan, 48084, United States

Location

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Missoula, Montana, 59808, United States

Location

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Brooklyn, New York, 11215, United States

Location

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Garden City, New York, 11530, United States

Location

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New York, New York, 10016, United States

Location

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Poughkeepsie, New York, 12601, United States

Location

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Concord, North Carolina, 28025, United States

Location

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Salisbury, North Carolina, 28144, United States

Location

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Winston-Salem, North Carolina, 27103, United States

Location

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Cincinnati, Ohio, 45212, United States

Location

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Columbus, Ohio, 43220, United States

Location

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Edmond, Oklahoma, 73034, United States

Location

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Bala-Cynwyd, Pennsylvania, 19004, United States

Location

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Knoxville, Tennessee, 37920, United States

Location

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Arlington, Texas, 76017, United States

Location

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Dallas, Texas, 75390, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Seattle, Washington, 98166, United States

Location

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Adelaide, South Australia, 5000, Australia

Location

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Bentleigh East, Victoria, 3165, Australia

Location

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Mentone, Victoria, 3194, Australia

Location

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Nedlands, Western Australia, 6009, Australia

Location

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Victoria, British Columbia, V8V 3N1, Canada

Location

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Saint John, New Brunswick, E2L 3J8, Canada

Location

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Kitchener, Ontario, N2N 3B9, Canada

Location

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Garches, 92380, France

Location

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Lyon, 69437, France

Location

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Nice, 06002, France

Location

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Nîmes, 30029, France

Location

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Orléans, 45067, France

Location

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Toulouse, 31059, France

Location

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Bad Bergzaben, 76887, Germany

Location

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Berlin, 14057, Germany

Location

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Hamburg, 20354, Germany

Location

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Holzminden, D-37603, Germany

Location

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Marburg, 35039, Germany

Location

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Oranienburg, 16515, Germany

Location

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Reutlingen, 72764, Germany

Location

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Heraklion, 71110, Greece

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Larissa, 41221, Greece

Location

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Pátrai, 26500, Greece

Location

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Thessaloniki, 56429, Greece

Location

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Cefalà Diana, 90015, Italy

Location

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Florence, 50012, Italy

Location

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Rome, 00161, Italy

Location

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Moscow, 127473, Russia

Location

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Rostov-on-Don, 344011, Russia

Location

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Saint Petersburg, 196247, Russia

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

erteberel

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 2, 2010

Study Start

April 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 8, 2019

Results First Posted

April 8, 2019

Record last verified: 2019-03

Locations

FR(6)US(40)CA(3)RU(3)DE(7)GR(4)IT(3)AU(4)