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En undersøgelse af mænd med lavt testosteronniveau for at måle effekten af ​​testosteronopløsning på testosteronniveauer, sexlyst og energi

24. november 2015 opdateret af: Eli Lilly and Company

Et randomiseret, dobbeltblindt, placebokontrolleret parallelt studie med en Open-Label-udvidelse for at vurdere effekten af ​​testosteronopløsning på totalt testosteron, sexlyst og energi hos hypogonadale mænd

Hovedformålet med denne undersøgelse er at evaluere, om testosteronopløsning kan hæve testosteronhormonniveauet til det normale område, og også forbedre niveauet af seksuel ophidselse, interesse og drive og/eller energiniveau hos mænd med lavt testosteronniveau og nedsat seksuel ophidselse, interesse og drive og/eller nedsat energi. Undersøgelsen vil vare omkring 16 uger, efterfulgt af en valgfri 24 ugers åben behandlingsfase for at undersøge den langsigtede sikkerhed af testosteronopløsning.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

715

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • 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.
      • Caba, Argentina
        • 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
    • Alberta
      • Calgary, Alberta, Canada
        • 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.
    • British Columbia
      • Victoria, British Columbia, Canada
        • 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
      • Barrie, Ontario, Canada
        • 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.
      • Burlington, Ontario, Canada
        • 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.
      • Kingston, Ontario, Canada
        • 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.
      • Kitchener, Ontario, Canada
        • 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.
      • London, Ontario, Canada
        • 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.
    • Quebec
      • Sherbrooke, Quebec, Canada
        • 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.
  • Det Forenede Kongerige
      • Barnsley, Det Forenede Kongerige
        • 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.
    • Greater London
      • London, Greater London, Det Forenede Kongerige
        • 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.
    • Manchester
      • Hathersage Road, Manchester, Det Forenede Kongerige
        • 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
      • Homewood, Alabama, Forenede Stater
        • 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.
    • Arizona
      • Chandler, Arizona, Forenede Stater
        • 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.
      • Glendale, Arizona, Forenede Stater
        • 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.
      • Mesa, Arizona, Forenede Stater
        • 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.
      • Phoenix, Arizona, Forenede Stater
        • 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.
      • Tempe, Arizona, Forenede Stater
        • 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.
      • Tucson, Arizona, Forenede Stater
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    • California
      • Escondido, California, Forenede Stater
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      • Irvine, California, Forenede Stater
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      • Los Angeles, California, Forenede Stater
        • 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.
      • Spring Valley, California, Forenede Stater
        • 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
      • Colorado Springs, Colorado, Forenede Stater
        • 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
      • Coral Springs, Florida, Forenede Stater
        • 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.
      • Daytona Beach, Florida, Forenede Stater
        • 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.
      • Fort Lauderdale, Florida, Forenede Stater
        • 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.
      • Jacksonville, Florida, Forenede Stater
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      • Oviedo, Florida, Forenede Stater
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      • Plantation, Florida, Forenede Stater
        • 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.
      • St. Petersburg, Florida, Forenede Stater
        • 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
      • Idaho Falls, Idaho, Forenede Stater
        • 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
        • 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
      • Crystal Lake, Illinois, Forenede Stater
        • 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
        • 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.
      • Indianapolis, Indiana, Forenede Stater
        • 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
      • Des Moines, Iowa, Forenede Stater
        • 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
      • Topeka, Kansas, Forenede Stater
        • 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
        • 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
        • 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.
    • Missouri
      • Springfield, Missouri, Forenede Stater
        • 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.
    • Nevada
      • Las Vegas, Nevada, Forenede Stater
        • 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 Jersey
      • Englewood, New Jersey, Forenede Stater
        • 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.
      • Toms River, New Jersey, Forenede Stater
        • 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
      • Raleigh, North Carolina, Forenede Stater
        • 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.
      • Wilmington, North Carolina, Forenede Stater
        • 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
      • Columbus, Ohio, Forenede Stater
        • 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
        • 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.
    • South Carolina
      • Greer, South Carolina, Forenede Stater
        • 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.
      • Mt. Pleasant, South Carolina, Forenede Stater
        • 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
      • Kingsport, Tennessee, Forenede Stater
        • 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
      • Austin, Texas, Forenede Stater
        • 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.
      • Houston, Texas, Forenede Stater
        • 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.
    • Utah
      • Clinton, Utah, Forenede Stater
        • 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
      • Bellevue, Washington, Forenede Stater
        • 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.
      • Seattle, Washington, Forenede Stater
        • 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.
      • Spokane, Washington, Forenede Stater
        • 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
      • Ancona, Italien
        • 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.
      • Bergamo, Italien
        • 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.
      • Bologna, Italien
        • 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.
      • Catania, Italien
        • 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
        • 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
        • 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.
      • Rozzano, Italien
        • 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.
      • Torino, Italien
        • 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.
  • Korea, Republikken
      • Goyang-Si, Korea, Republikken
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      • Jeon Ju-City, Korea, Republikken
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      • Kwang Ju, Korea, Republikken
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      • Pusan, Korea, Republikken
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      • Seoul, Korea, Republikken
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  • Puerto Rico
      • San Juan, Puerto Rico
        • 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.
  • Spanien
      • Aravaca, Spanien
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      • Barcelona, Spanien
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      • Coslada, Spanien
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      • La Coruña, Spanien
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      • Madrid, Spanien
        • 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.
      • Majadahonda, Spanien
        • 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
      • Berlin, Tyskland
        • 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.
      • Halle, Tyskland
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      • Hamburg, Tyskland
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      • Hettstedt, Tyskland
        • 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
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      • Marburg, Tyskland
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      • Münster, Tyskland
        • 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

18 år og ældre (VOKSEN, OLDER_ADULT)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inklusionskriterier:

  • Samlet testosteronniveau <300 nanogram pr. deciliter (ng/dL) [10,4 nanomol pr. liter (nmol/L)] ved hvert af 2 screeningsbesøg
  • Mindst 1 symptom på testosteronmangel, som skal omfatte nedsat energi eller nedsat seksualdrift
  • Prostataspecifikt antigen (PSA) <4 nanogram pr. milliliter (ng/ml) ved screening

Ekskluderingskriterier:

  • Seksuel partner, der er eller bliver gravid på et hvilket som helst tidspunkt under undersøgelsen
  • Brug af langtidsvirkende intramuskulær (IM) testosteron undecanoat eller testosteron pellets i den 6-måneders periode før screening
  • Body Mass Index (BMI) >37 kilogram pr. kvadratmeter (kg/m^2) ved screening
  • Alvorlige symptomer i de nedre urinveje og/eller betydelig prostataforstørrelse
  • Prolactin laboratorietestresultat på >30 ng/ml ved screening
  • Hæmoglobin A1c (HbA1c) >11 % ved screening
  • Hæmatokrit ≥50 % (>54 % i forhøjet højde) ved screening
  • Nuværende brug af medicin, naturlægemidler og/eller kosttilskud, der kan forstyrre testosteron
  • Dermatologisk tilstand i underarmsområdet, der kan forstyrre testosteronabsorptionen (f.eks. eksem) eller blive forværret af lokal testosteronerstatningsterapi
  • Modtager i øjeblikket behandling med cancerkemoterapi eller antiandrogener
  • Kronisk brug af systemiske glukokortikoider (brug i >14 dage inden for de 3 måneder før screening); brug af ikke-testosteron anabolske steroider inden for 12 måneder før screening
  • Konkurrence-atleter involveret i en sport, hvor de kan blive screenet for anabolske steroider
  • Anamnese med brug af østrogeniserende midler inden for 12 måneder før screening
  • Anamnese med behandling med luteiniserende hormon-frigørende hormonantagonist eller agonist i de sidste 6 måneder før screening
  • Anamnese med clomiphene eller anden anti-østrogenbehandling i de 3 måneder før screening
  • Brug af finasterid inden for 3 måneder før screening eller brug af dutasterid inden for 6 måneder før screening
  • Nuværende brug af warfarin eller phenprocoumon
  • Anamnese med hyppig opioidbrug: >1 gang/uge i løbet af en uge inden for 30 dage før screening
  • Nuværende brug af dopaminreceptoragonister (cabergolin, pergolid, bromocriptin)
  • Har en historie med betydelige centralnervesystemskader eller sygdom (herunder slagtilfælde, rygmarvsskade eller dissemineret sklerose) inden for 6 måneder før screening
  • Systolisk blodtryk >170 eller <90 millimeter kviksølv (mm Hg) eller diastolisk blodtryk >100 eller <50 mm Hg ved screening eller en historie med malign hypertension
  • Anamnese med ustabil angina som defineret af Braunwald Klassifikation af ustabil angina eller angina, der er opstået under samleje i de sidste 6 måneder
  • Anamnese med nogen af ​​følgende koronartilstande inden for 90 dage efter screening: myokardieinfarkt, koronar bypassoperation, perkutan koronar intervention (angioplastik eller stentplacering)
  • Har nogen supraventrikulær arytmi med en ukontrolleret ventrikulær respons [gennemsnitlig hjertefrekvens >100 slag i minuttet (bpm)] i hvile, eller har en historie med spontan eller induceret vedvarende ventrikulær takykardi (puls >100 slag i minuttet i ≥30 sekunder), eller brug af en automatisk intern cardioverter-defibrillator
  • Har en historie med pludseligt hjertestop
  • Vis tegn på kongestiv hjertesvigt [New York Heart Association (NYHA) klasse 2 eller derover] inden for 6 måneder før screening
  • Har haft en ny, betydelig hjerteledningsfejl inden for 90 dage før screening
  • Klinisk mistanke (eller historie) om prostatacancer under digital rektalundersøgelse ved screening
  • Kendt eller mistænkt brystkræft (eller historie med brystkræft) eller anden aktiv cancer (med undtagelse af ikke-melanotisk hudkræft)
  • Udvise tegn på alvorlig nyreinsufficiens [kreatininclearance <30 milliliter pr. minut (mL/min) som bestemt ved Cockcroft-Gault-formlen] ved screening
  • Udvise en anamnese med alvorlig leversygdom eller kliniske tegn på nedsat leverfunktion ved screening
  • Har en historie med human immundefektvirus (HIV) infektion
  • Alvorlig søvnapnø
  • Ubehandlet hypothyroidisme, hypercortisolisme eller anden væsentlig endokrinopati (bortset fra hypogonadisme), der bidrager til symptomer på lav energi eller træthed

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: TILFÆLDIGT
  • Interventionel model: PARALLEL
  • Maskning: TRIPLE

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
PLACEBO_COMPARATOR: Placebo løsning
Placeboopløsning påført topisk én gang dagligt i 12 uger.
Medicin: Placebo løsning
Indgives topisk til aksiller.
EKSPERIMENTEL: Testosteronopløsning
Testosteronopløsning 60 milligram (mg) påført topisk én gang dagligt med mulig titrering ned til 30 milligram per dag (mg/dag) eller op til 120 mg/dag i 12 uger og valgfri forlængelse i 24 uger.
Medicin: Testosteronopløsning
Indgives topisk til aksiller.
Andre navne:
  • LY900011
  • Axiron
  • Testosteronopløsning 2%

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal deltagere med total serumtestosteronkoncentration inden for normalområdet i uge 12
Tidsramme: Uge 12
Normalområdet for totalt serum testosteron blev defineret som 300 til 1050 nanogram pr. deciliter (ng/dL).
Uge 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skift fra baseline til uge 12 i seksuel ophidselse, interesse og drivkraft (SAID)-skalaresultater
Tidsramme: Baseline, uge ​​12
SAID-skalaen er et selvadministreret instrument, der bruges til at vurdere seksuel ophidselse, interesse og sexlyst hos mænd med symptomatisk hypogonadisme. SAID'et består af 5 spørgsmål, der blev bedømt på en skala fra 1 til 5, hvor "5" svarer til større niveauer af seksuel ophidselse, interesse eller drive. SAID-skalaens samlede score blev beregnet ved at summere elementscorerne og lineært transformere summen til en skala fra 0 til 100, med højere score svarende til større seksuel ophidselse, interesse og drive. Mindste kvadraters (LS) middelændring fra baseline blev beregnet ved hjælp af en analyse af kovarians (ANCOVA) med behandlingsgruppen og basislinjeværdien som kovariater.
Baseline, uge ​​12
Skift fra baseline til uge 12 i Hypogonadism Energy Diary (HED) resultater
Tidsramme: Baseline, uge ​​12
HED er et selvadministreret instrument, der bruges til at vurdere energiniveauer i realtid hos mænd med symptomatisk hypogonadisme. Den består af 2 spørgsmål, der blev scoret på en skala fra 0 til 10, hvor "10" svarer til "Fuld af Energi" eller "Slet ikke træt" (Træthedsskalaen blev omvendt kortlagt, da den blev indsamlet med "10 " svarende til "Ekstrem træthed"). Spørgeskemaet blev udfyldt 3 gange dagligt (dannende 6 unikke emner) i 7 på hinanden følgende dage. Varescore blev beregnet ved at tage et gennemsnit af værdierne for hver vare på tværs af 7 dage. Hvis der manglede mere end 2 dage for en vare, manglede varens score. Den samlede score blev beregnet ved at summere elementscorerne og lineært transformere summen til en skala fra 0 til 100, med højere score svarende til større energi. Hvis der manglede en elementscore, manglede den samlede score. LS gennemsnitlig ændring fra baseline blev beregnet ved hjælp af ANCOVA med behandlingsgruppe og basislinjeværdien som kovariater.
Baseline, uge ​​12
Antal deltagere med prostataspecifikt antigen (PSA) >4 nanogram/milliliter (ng/mL)
Tidsramme: Double Blind Baseline, uge ​​12, Open Label Baseline, uge ​​36
Double Blind Baseline, uge ​​12, Open Label Baseline, uge ​​36

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i Total International Prostate Symptom Score (IPSS)
Tidsramme: Baseline, uge ​​12, uge ​​36
IPSS er et selvadministreret instrument, der bruges til at vurdere sværhedsgraden af ​​symptomer i de nedre urinveje. IPSS består af 7 spørgsmål, der blev scoret på en skala fra 0 (ingen/ingen symptomer) til 5 (hyppige symptomer), for et samlet scoreområde på 0 til 35. Højere numeriske score fra IPSS-spørgeskemaet repræsenterer større sværhedsgrad af symptomer. LS gennemsnitlig ændring fra baseline blev beregnet ved hjælp af ANCOVA med behandlingsgruppe og basislinjeværdien som kovariater.
Baseline, uge ​​12, uge ​​36

Samarbejdspartnere og efterforskere

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

Sponsor

Eli Lilly and Company

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. maj 2013

Primær færdiggørelse (FAKTISKE)

1. oktober 2014

Studieafslutning (FAKTISKE)

1. april 2015

Datoer for studieregistrering

Først indsendt

19. marts 2013

Først indsendt, der opfyldte QC-kriterier

19. marts 2013

Først opslået (SKØN)

22. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (SKØN)

28. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 14396
  • I5E-MC-TSAT (ANDET: Eli Lilly and Company)
  • 2012-004866-16 (EUDRACT_NUMBER)

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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