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A Study of LY900010 in Erectile Dysfunction

11. marts 2019 opdateret af: Eli Lilly and Company

A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction

The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.

Studieoversigt

Status

Afsluttet

Betingelser

Erektil dysfunktion

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

410

Fase

Fase 2

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35209
    - 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
  - Phoenix, Arizona, Forenede Stater, 85050
    - 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.
  - Irvine, California, Forenede Stater, 92618
    - 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.
  - Long Beach, California, Forenede Stater, 90806
    - 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.
  - Sacramento, California, Forenede Stater, 95825
    - 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, 92120
    - 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.
  - Vacaville, California, Forenede Stater, 95688
    - 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, 80220
    - 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.
  - Englewood, Colorado, Forenede Stater, 80113
    - 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.
  - 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.
  - Jacksonville, Florida, Forenede Stater, 32209
    - 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.
  - Plantation, Florida, Forenede Stater, 33317
    - 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.
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46256
    - 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, 50314
    - 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
  - Overland Park, Kansas, Forenede Stater, 66215
    - 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.
  - Topeka, Kansas, Forenede Stater, 66606
    - 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.
- 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.
- Missouri
  - Saint Louis, Missouri, Forenede Stater, 63141
    - 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, 89117
    - 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
  - Cary, North Carolina, Forenede Stater, 27511
    - 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.
  - Charlotte, North Carolina, Forenede Stater, 28207
    - 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.
  - Raleigh, North Carolina, Forenede Stater, 27607
    - 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.
- 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.
- 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
  - Dallas, Texas, Forenede Stater, 75234
    - 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
  - Bellevue, Washington, Forenede Stater, 98007
    - 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.
  - Olympia, Washington, Forenede Stater, 98502
    - 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, 99202
    - 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 til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria include:

Ambulatory men
History of erectile dysfunction of at least 3 months duration
History of incomplete response to any phosphodiesterase type 5 inhibitor (PDE5i) at the maximum tolerated dose within the label
Anticipate having the same female sexual partner throughout the duration of the study
Are willing and able to make at least 4 sexual intercourse attempts with the female sexual partner during each 4-week segment of the study
Agree to use birth control during the study and for 60 days after the study, unless the female partner is postmenopausal
Agree not to use any other erectile dysfunction treatment, including herbal treatment, during the study and for 96 hours after the last dose of study drug
Screening laboratory tests within normal limits except for testosterone
Without a language barrier, are reliable and willing to follow study procedures
Prostate-specific antigen (PSA) less than 10 nanograms per milliliter (ng/ml). Men with PSA greater than 4 and less than 10 ng/ml must have documentation of a negative histological biopsy of carcinoma of prostate within 12 months prior to screening

Exclusion Criteria include:

History of penile implant
History of no response to injection therapy for erectile dysfunction
History of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection
Exhibit the presence of clinically significant penile deformity in the opinion of the investigator
History of prior sexual legal convictions
Bilateral hip replacements
History of cancer within the previous 5 years, except for excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin
Chronic stable angina currently treated with long-acting nitrates
Chronic stable angina requiring treatment with short-acting nitrates within 90 days prior to screening
Angina occurring during sexual intercourse in the 6 months prior to screening
Unstable angina within 6 months prior to screening
Myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening
Angioplasty or stent placement within 90 days prior to screening
Congestive heart failure within 6 months prior to screening
History of sudden cardiac arrest
Supraventricular arrhythmia with an uncontrolled ventricular response at rest, or any history of spontaneous or induced sustained ventricular tachycardia, or use an automatic internal cardioverter-defibrillator
An abnormality in the 12-lead electrocardiogram (ECG) that in the opinion of the investigator places the subject in an unacceptable risk for study participation
Systolic blood pressure greater than 170 or less than 90 millimeters of mercury (mm Hg) or diastolic blood pressure greater than 100 or less than 50 mm Hg at screening
Hepatic, renal, human immunodeficiency virus (HIV), or clinically significant active neuropsychiatric disease
History of central nervous system injuries (including stroke or spinal cord injury) within 6 months prior to screening
Alcohol intake of 5 units or greater per day (1 unit = 12 ounces beer, 5 ounces wine, or 1.5 ounces of 80-proof distilled spirits)
Receiving treatment with antiandrogens or 5-alpha reductase inhibitor
Anabolic steroids, calcitonin, oral bisphosphonates, Vitamin D greater than 50,000 international units per week (IU/week), dehydroepiandrosterone (DHEA), steroidal supplements, nutritional products intended to have weight reduction or performance enhancing effects, herbal supplements within 7 days prior to screening
Currently treated with a potent cytochrome P450 (CYP) 3A4 inhibitor, such as systemic ketoconazole or ritonavir, or a CYP3A4 inducer such as rifampicin

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: Dobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: 1 milligram (mg) LY2452473 + 5 mg tadalafil	Medicin: LY2452473 Administered orally, once daily for 12 weeks Medicin: tadalafil Administered orally, once daily for 12 weeks Medicin: placebo (tadalafil) Administered orally, once daily for 12 weeks
Eksperimentel: 5 mg LY2452473 + 5 mg tadalafil	Medicin: LY2452473 Administered orally, once daily for 12 weeks Medicin: tadalafil Administered orally, once daily for 12 weeks Medicin: placebo (tadalafil) Administered orally, once daily for 12 weeks
Eksperimentel: 5 mg LY2452473 + placebo	Medicin: LY2452473 Administered orally, once daily for 12 weeks Medicin: placebo (tadalafil) Administered orally, once daily for 12 weeks
Aktiv komparator: 10 mg tadalafil + placebo	Medicin: tadalafil Administered orally, once daily for 12 weeks Medicin: placebo (tadalafil) Administered orally, once daily for 12 weeks Medicin: placebo (LY2452473) Administered orally, once daily for 12 weeks
Aktiv komparator: 5 mg tadalafil + placebo	Medicin: tadalafil Administered orally, once daily for 12 weeks Medicin: placebo (tadalafil) Administered orally, once daily for 12 weeks Medicin: placebo (LY2452473) Administered orally, once daily for 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score Tidsramme: Baseline, Week 12	The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.	Baseline, Week 12

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary Tidsramme: Baseline, Week 12	The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value <0.25).	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) Tidsramme: Baseline, Week 12	Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value<0.25).	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25) Tidsramme: Baseline, Week 12	The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to >25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups Tidsramme: Baseline, Week 12	The International Index of Erectile Function (IIEF) EF was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF Self-reported questionnaire. Q1 to Q5 were rated 0 (low/no erectile function) to 5 (high erectile function) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF. Testosterone concentration subgroups were based on optimal baseline testosterone levels (<340 nanograms per deciliter [ng/dL] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline*treatment interaction (if p-value<0.25).	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) Tidsramme: Baseline, Week 12	The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value<0.25).	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides Tidsramme: Baseline, Week 12	The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value<0.25).	Baseline, Week 12
Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C) Tidsramme: Baseline, Week 12	The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value<0.25).	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Glucose Tidsramme: Baseline, Week 12	The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value<0.25).	Baseline, Week 12
Change From Baseline to 12 Week Endpoint in Fasting Insulin Tidsramme: Baseline, Week 12	Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatmentvisit, baseline, baselinetreatment (if p-value<0.25).	Baseline, Week 12

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. oktober 2010

Primær færdiggørelse (Faktiske)

1. november 2011

Studieafslutning (Faktiske)

1. november 2011

Datoer for studieregistrering

Først indsendt

8. juli 2010

Først indsendt, der opfyldte QC-kriterier

8. juli 2010

Først opslået (Skøn)

12. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. 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

11888
I4K-MC-GPEC (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 .

Kliniske forsøg med Erektil dysfunktion

Consorcio Centro de Investigación Biomédica en...
Hospital General Universitario Gregorio Marañon; Universidad Complutense... og andre samarbejdspartnere

Ikke rekrutterer endnu

Træning for en aldrende lever (EXALIVER) (EXALIVER)

Leverfibrose/NASH | MASH - Metabolic Dysfunction-Associated Steatohepatitis | MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Spanien
Rivus Pharmaceuticals, Inc.

Rekruttering

Et forsøg til at undersøge sikkerhed, eksponering og effekt af HU6 sammenlignet med placebo hos voksne deltagere med metabolisk dysfunktions-associeret steatohepatitis (MASH) (AMPLIFY)

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Forenede Stater
Madrigal Pharmaceuticals, Inc.

Rekruttering

Rezdiffra Graviditets- og Ammeplejeregister

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Forenede Stater
Shanghai East Hospital

Rekruttering

Højrisiko-transkriptom molekylær forudsigelsesundersøgelse af MASH-associerede kolorektale polypper

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Kina
Southern California Institute for Research and...

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En fase II RCT-undersøgelse af betain versus placebo for serologisk diagnosticeret metabolisk dysfunktions-associeret steatohepatitis (MASH)

MASH - Metabolic Dysfunction-Associated Steatohepatitis
Nabiqasim Industries (Pvt) Ltd

Rekruttering

Resmiterom Effektivitet & Sikkerhed hos Patienter med MASH (REZMASH)

MASH - Metabolic Dysfunction-Associated Steatohepatitis

Pakistan
Stimdia Medical, Inc.

Afsluttet

PEPNS System Feasibility Undersøgelse

Ventilator-induceret diaphragmatic dysfunction (VIDD)

Irland, Tjekkiet
Fondazione Policlinico Universitario Agostino Gemelli...

Rekruttering

Måling af miltstivhed til detektering af avanceret fibrose (S-MASH)

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Italien
Tangram Therapeutics Plc

Rekruttering

Undersøgelse af TGM-312-SC01 hos raske deltagere og voksne med MASH

Sunde deltagere | MASH - Metabolic Dysfunction-Associated Steatohepatitis

Det Forenede Kongerige
University of Campania Luigi Vanvitelli

Afsluttet

Effekter af langvarig bicarbonat-sulfat-calcium-magnesiumvandsindtag på metabolisk dysfunktion-associeret steatotisk leversygdom (MASLD) -relateret resultat (FonteESSEMASLD)

MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease

Italien

Kliniske forsøg med LY2452473

Eli Lilly and Company

Afsluttet

Disponering af 14C-LY2452473 efter oral administration hos raske mennesker

Sunde frivillige

Forenede Stater
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)

Afsluttet

En selektiv androgenreceptormodulator til symptombehandling ved prostatacancer

Prostatakræft

Forenede Stater
Eli Lilly and Company

Afsluttet

En biotilgængelighedsundersøgelse af LY2452473 og Tadalafil

Erektil dysfunktion

Forenede Stater

A Study of LY900010 in Erectile Dysfunction

A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Erektil dysfunktion

Kliniske forsøg med LY2452473

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Brazil

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer