A Study in Men With Benign Prostatic Hyperplasia

NCT ID: NCT01097707

Last Updated: 2019-04-08

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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Conditions

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Benign Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1mg LY500307

Group Type EXPERIMENTAL

LY500307

Intervention Type DRUG

Administered orally, daily for 24 weeks

3mg LY500307

Group Type EXPERIMENTAL

LY500307

Intervention Type DRUG

Administered orally, daily for 24 weeks

10mg LY500307

Group Type EXPERIMENTAL

LY500307

Intervention Type DRUG

Administered orally, daily for 24 weeks

25mg LY500307

Group Type EXPERIMENTAL

LY500307

Intervention Type DRUG

Administered orally, daily for 24 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally, daily for 24 weeks

Interventions

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LY500307

Administered orally, daily for 24 weeks

Intervention Type DRUG

Placebo

Administered orally, daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Huntsville, Alabama, United States

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Anchorage, Alaska, United States

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Glendora, California, United States

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Newport Beach, California, United States

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San Bernardino, California, United States

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San Diego, California, United States

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Tarzana, California, United States

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Denver, Colorado, United States

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Parker, Colorado, United States

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Middlebury, Connecticut, United States

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Aventura, Florida, United States

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Bradenton, Florida, United States

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Celebration, Florida, United States

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Coral Springs, Florida, United States

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Coeur d'Alene, Idaho, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Fort Wayne, Indiana, United States

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West Des Moines, Iowa, United States

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Wichita, Kansas, United States

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Shreveport, Louisiana, United States

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Greenbelt, Maryland, United States

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Troy, Michigan, United States

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Missoula, Montana, United States

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Brooklyn, New York, United States

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Garden City, New York, United States

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New York, New York, United States

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Poughkeepsie, New York, United States

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Concord, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Edmond, Oklahoma, United States

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Bala-Cynwyd, Pennsylvania, United States

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Knoxville, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Adelaide, South Australia, Australia

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Bentleigh East, Victoria, Australia

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Mentone, Victoria, Australia

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Nedlands, Western Australia, Australia

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Victoria, British Columbia, Canada

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Saint John, New Brunswick, Canada

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Kitchener, Ontario, Canada

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Garches, , France

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Lyon, , France

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Nice, , France

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Nîmes, , France

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Orléans, , France

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Toulouse, , France

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Bad Bergzaben, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Holzminden, , Germany

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Marburg, , Germany

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Oranienburg, , Germany

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Reutlingen, , Germany

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Heraklion, , Greece

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Larissa, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Cefalà Diana, , Italy

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Florence, , Italy

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Rome, , Italy

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Moscow, , Russia

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Rostov-on-Don, , Russia

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Saint Petersburg, , Russia

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Countries

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United States Australia Canada France Germany Greece Italy Russia

Other Identifiers

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I1A-MC-BPAE

Identifier Type: OTHER

Identifier Source: secondary_id

10373

Identifier Type: -

Identifier Source: org_study_id

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