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En undersøgelse af mænd med benign prostatahyperplasi

11. marts 2019 opdateret af: Eli Lilly and Company

Et klinisk fase 2-studie til evaluering af daglige orale doser af LY500307 i 24 uger hos mænd med symptomer på nedre urinveje (LUTS) og prostataforstørrelse sekundært til benign prostatahyperplasi (BPH)

Formålet med undersøgelsen er at afgøre, om LY500307 hjælper på symptomer på benign prostatahyperplasi (BPH)

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

414

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Australien
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Victoria
      • Bentleigh East, Victoria, Australien, 3165
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mentone, Victoria, Australien, 3194
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3N1
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Brunswick
      • St. John, New Brunswick, Canada, E2L 3J8
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ontario
      • Kitchener, Ontario, Canada, N2N 3B9
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 127473
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rostov-On-Don, Den Russiske Føderation, 344011
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Saint Petersburg, Den Russiske Føderation, 196247
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Forenede Stater
    • Alabama
      • Huntsville, Alabama, Forenede Stater, 35801
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • California
      • Glendora, California, Forenede Stater, 91741
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Newport Beach, California, Forenede Stater, 92660
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Bernardino, California, Forenede Stater, 92404
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Diego, California, Forenede Stater, 92103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tarzana, California, Forenede Stater, 91356
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Denver, Colorado, Forenede Stater, 80210
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Parker, Colorado, Forenede Stater, 80134
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Connecticut
      • Middlebury, Connecticut, Forenede Stater, 06762
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Aventura, Florida, Forenede Stater, 33180
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Bradenton, Florida, Forenede Stater, 34205
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Celebration, Florida, Forenede Stater, 34747
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Coral Springs, Florida, Forenede Stater, 33065
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Idaho
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Meridian, Idaho, Forenede Stater, 83642
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Indiana
      • Fort Wayne, Indiana, Forenede Stater, 46825
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67708
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71106
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Greenbelt, Maryland, Forenede Stater, 20770
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Michigan
      • Troy, Michigan, Forenede Stater, 48084
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Montana
      • Missoula, Montana, Forenede Stater, 59808
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Brooklyn, New York, Forenede Stater, 11215
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Garden City, New York, Forenede Stater, 11530
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New York, New York, Forenede Stater, 10016
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Poughkeepsie, New York, Forenede Stater, 12601
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Concord, North Carolina, Forenede Stater, 28025
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Salisbury, North Carolina, Forenede Stater, 28144
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45212
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Columbus, Ohio, Forenede Stater, 43220
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oklahoma
      • Edmond, Oklahoma, Forenede Stater, 73034
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, Forenede Stater, 19004
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Arlington, Texas, Forenede Stater, 76017
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Dallas, Texas, Forenede Stater, 75390
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Antonio, Texas, Forenede Stater, 78229
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Washington
      • Seattle, Washington, Forenede Stater, 98166
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Frankrig
      • Garches, Frankrig, 92380
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Lyon, Frankrig, 69437
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nice, Frankrig, 06002
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Nimes, Frankrig, 30029
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Orleans, Frankrig, 45067
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Toulouse, Frankrig, 31059
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Grækenland
      • Heraklion, Grækenland, 71110
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Larissa, Grækenland, 41221
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Patras, Grækenland, 26500
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Thessaloniki, Grækenland, 56429
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Italien
      • Cefala, Italien, 90015
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Firenze, Italien, 50012
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Rome, Italien, 00161
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Tyskland
      • Bad Bergzabern, Tyskland, 76887
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Berlin, Tyskland, 14057
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Hamburg, Tyskland, 20354
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Holzminden, Tyskland, D-37603
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Marburg, Tyskland, 35039
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Oranienburg, Tyskland, 16515
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Reutlingen, Tyskland, 72764
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

45 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inklusionskriterier:

  • Til stede ved screening med en historie med benign prostatahyperplasi (BPH) i >6 måneder.
  • Har en International Prostate Symptom Score (IPSS) større end eller lig med 13 ved screening.
  • Har et samlet prostatavolumen ved transrektal ultralyd større end eller lig med 30 milliliter (ml) ved screening.
  • Vis tegn på blæreudløbsobstruktion som defineret ved en maksimal urinstrømshastighed (Qmax) større end eller lig med 4 og mindre end eller lig med 15 milliliter/sekund (mL/sek) (fra en forudgående total blærevolumen [vurderet ved ultralyd] på større end eller lig med 150 til mindre end eller lig med 550 ml og et minimum tømt volumen på 125 ml) ved screening.
  • Har et prostataspecifikt antigen (PSA) større end eller lig med 1,4 og mindre end eller lig med 10 nanogram/milliliter (ng/ml) ved screening.
  • Demonstrer en Post Void-rest på mindre end eller lig med 300 ml ved ultralyd ved screening.

  • Har ikke modtaget følgende behandlinger inden for det angivne tidsrum:

    1. Finasterid eller dutasterid i mindst 6 måneder før screening.
    2. Eventuelle alfa-adrenerge antagonister i mindst 4 uger før screening.
    3. Enhver anden ikke-eksperimentel BPH-behandling (inklusive et urtepræparat) i mindst 4 uger før screening.
    4. Enhver anden eksperimentel eller off-label BPH-terapi, såsom injicerbare terapier med en langvarig effekt i mindst 6 måneder før screening.
    5. Enhver overaktiv blærebehandling i mindst 4 uger før screening.
    6. Enhver behandling med erektil dysfunktion, som kan omfatte orale phosphodiesterase type 5-hæmmere eller udstyr i mindst 4 uger før screening.
  • Hav en morgenfastende Total testosteronkoncentration større end eller lig med 300 nanogram/deciliter (ng/dL) ved screening.
  • Hvis hyperlipidæmi, baseret på historie, være stabil på statinbehandling som bestemt af investigator i mindst 2 måneder før screening.

Ekskluderingskriterier:

  • Har afsluttet eller trukket sig fra denne undersøgelse eller har afsluttet eller trukket sig fra enhver anden undersøgelse, der undersøger LY500307.
  • Har nogen historie med BPH-relaterede invasive procedurer (for eksempel transurethral resektion af prostata, åben prostatektomi og minimalt invasive procedurer, der inkluderer termisk-baserede terapier, transurethral mikrobølgebehandling, transurethral nåleablation og stents).

  • Har aktiv kardiovaskulær sygdom som påvist af følgende:

    1. Nylig myokardieinfarkt, ustabil angina, slagtilfælde eller forbigående iskæmisk anfald inden for 6 måneder efter screening.
    2. Nylig koronarintervention, der inkluderer koronar bypass-operation, perkutan koronararterieindgreb eller stentplacering inden for 6 måneder efter screening.
    3. Nylig historie med positive stresstests uden nogen skriftlig dokumentation for effektiv intervention inden for 6 måneder efter screening.
    4. Bevis på hjertesygdom kategoriseret som større end eller lig med klasse III funktionel klassifikation af New York Heart Association (NYHA) inden for 6 måneder efter screening.
  • Har kendt eller mistænkt historie med prostatacancer, brystkræft eller anden klinisk signifikant neoplastisk sygdom (bortset fra pladecelle- eller basalcellekarcinom i huden).
  • Har en historie med dyb venøs trombose eller lungeemboli.
  • Har moderat til svær nyreinsufficiens.
  • Har et hæmoglobin A1c (HbA1c) større end 9,0 %.
  • Er i testosteronerstatningsterapi, eller medicin, der påvirker hypothalamus-hypofyse-gonadeaksen.
  • Er i anden farmakologisk behandling end statiner mod hyperlipidæmi.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Indgivet oralt, dagligt i 24 uger
Eksperimentel: 1mg LY500307
Medicin: LY500307
Indgivet oralt, dagligt i 24 uger
Eksperimentel: 3mg LY500307
Medicin: LY500307
Indgivet oralt, dagligt i 24 uger
Eksperimentel: 10mg LY500307
Medicin: LY500307
Indgivet oralt, dagligt i 24 uger
Eksperimentel: 25mg LY500307
Medicin: LY500307
Indgivet oralt, dagligt i 24 uger

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline til 24-ugers slutpunkt i International Prostate Symptom Score (IPSS) Total Score
Tidsramme: Baseline, 24 uger
IPSS Total Score er summen af ​​spørgsmål 1 til 7 i IPSS-spørgeskemaet. Hvert spørgsmål scores fra 0 (ingen/ingen symptomer) til 5 (hyppige symptomer) med et IPSS Total Score-område på 0-35 point. Højere numeriske score fra IPSS-spørgeskemaet repræsenterer større sværhedsgrad af symptomer.
Baseline, 24 uger

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procentvis ændring fra baseline til 24-ugers slutpunkt i total prostatavolumen (TPV)
Tidsramme: Baseline, 24 uger
TPV-målingen (milliliter) ved transrektal ultralyd (TRUS) er en etableret diagnostisk test for mænd med symptomer på nedre urinveje (LUTS) på grund af benign prostatahyperplasi (BPH).
Baseline, 24 uger
Ændring fra baseline til 24-ugers slutpunkt i maksimal urinstrømshastighed (Qmax)
Tidsramme: Baseline, 24 uger
Qmax er defineret som den maksimale urinflowhastighed målt ved hjælp af standardkalibreret uroflowmeter.
Baseline, 24 uger
Ændring fra baseline til 24-ugers slutpunkt i internationalt prostata symptomscore-livskvalitetsindeks (IPSS-QoL)
Tidsramme: Baseline, 24 uger
IPSS QoL vurderer deltagerens svar på følgende spørgsmål: "Hvis du skulle tilbringe resten af ​​dit liv med din urinvejstilstand, lige som den er nu, hvordan ville du så have det med det?" Svarmulighederne er Delighted (0), Pleased (1); For det meste tilfreds (2); Blandet-omtrent lige tilfreds og utilfreds (3); Mest utilfreds (4); Ulykkelig (5); Forfærdelig (6), med et samlet interval på 0-6.
Baseline, 24 uger
Skift fra baseline til 24-ugers slutpunkt i International Prostate Symptom Score (IPSS) lagring, tømning og Nocturia Subscores
Tidsramme: Baseline, 24 uger
IPSS Storage (Irritative) subscore er summen af ​​spørgsmål 2, 4 og 7 i IPSS-spørgeskemaet. Score varierer fra 0 (ingen irritative symptomer) til 5 (hyppige irritative symptomer), med en samlet underscore af de 3 spørgsmål for irritativ underscore fra 0 til 15. IPSS Voiding (Obstructive) subscore er summen af ​​spørgsmål 1, 3, 5 og 6 i IPSS-spørgeskemaet. Score varierer fra 0 (ingen obstruktive symptomer) til 5 (hyppige obstruktive symptomer), med en samlet underscore af de 4 spørgsmål i den obstruktive score fra 0 til 20. Nocturia Subscore er IPSS Spørgsmål 7, som vurderer, hvor mange gange i løbet af den sidste måned en deltager står op for at tisse fra de gik i seng om natten, til de stod op om morgenen. Score varierer fra 0=Ingen; 1=1 gang; 2= ​​2 gange; 3=3 gange; 4=4 gange; 5=5 eller flere gange.
Baseline, 24 uger
Procentvis ændring fra baseline til 24-ugers slutpunkt i prostataspecifikt antigen (PSA)
Tidsramme: Baseline, 24 uger
Enhederne for PSA-måling er nanogram pr. milliliter (ng/mL).
Baseline, 24 uger
Skift fra baseline til 24-ugers slutpunkt i fastende total testosteron
Tidsramme: Baseline, 24 uger
Baseline, 24 uger
Skift fra baseline til 24-ugers slutpunkt i lipidprofil
Tidsramme: Baseline, 24 uger
Lipidprofilen bestod af lavdensitetslipoproteinkolesterol (LDL-C), højdensitetslipoproteinkolesterol (HDL-C) og triglycerider.
Baseline, 24 uger

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2010

Primær færdiggørelse (Faktiske)

1. oktober 2011

Studieafslutning (Faktiske)

1. oktober 2011

Datoer for studieregistrering

Først indsendt

31. marts 2010

Først indsendt, der opfyldte QC-kriterier

31. marts 2010

Først opslået (Skøn)

2. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10373 (Anden identifikator: Fred Hutch/University of Washington Cancer Consortium)
  • I1A-MC-BPAE (Anden identifikator: Eli Lilly and Company)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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