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A Study of LY900010 in Erectile Dysfunction

11 de marzo de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Disfuncion erectil

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

410

Fase

Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Estados Unidos
- Alabama
  - Birmingham, Alabama, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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, Estados Unidos, 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.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

45 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Masculino

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Propósito principal: Tratamiento
Asignación: Aleatorizado
Modelo Intervencionista: Asignación paralela
Enmascaramiento: Doble

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo	Intervención / Tratamiento
Experimental: 1 milligram (mg) LY2452473 + 5 mg tadalafil	Droga: LY2452473 Administered orally, once daily for 12 weeks Droga: tadalafil Administered orally, once daily for 12 weeks Droga: placebo (tadalafil) Administered orally, once daily for 12 weeks
Experimental: 5 mg LY2452473 + 5 mg tadalafil	Droga: LY2452473 Administered orally, once daily for 12 weeks Droga: tadalafil Administered orally, once daily for 12 weeks Droga: placebo (tadalafil) Administered orally, once daily for 12 weeks
Experimental: 5 mg LY2452473 + placebo	Droga: LY2452473 Administered orally, once daily for 12 weeks Droga: placebo (tadalafil) Administered orally, once daily for 12 weeks
Comparador activo: 10 mg tadalafil + placebo	Droga: tadalafil Administered orally, once daily for 12 weeks Droga: placebo (tadalafil) Administered orally, once daily for 12 weeks Droga: placebo (LY2452473) Administered orally, once daily for 12 weeks
Comparador activo: 5 mg tadalafil + placebo	Droga: tadalafil Administered orally, once daily for 12 weeks Droga: placebo (tadalafil) Administered orally, once daily for 12 weeks Droga: placebo (LY2452473) Administered orally, once daily for 12 weeks

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary Periodo de tiempo: 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) Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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) Periodo de tiempo: 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 Periodo de tiempo: 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 Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2010

Finalización primaria (Actual)

1 de noviembre de 2011

Finalización del estudio (Actual)

1 de noviembre de 2011

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2010

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2010

Publicado por primera vez (Estimar)

12 de julio de 2010

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de abril de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

11 de marzo de 2019

Última verificación

1 de marzo de 2019

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

11888
I4K-MC-GPEC (Otro identificador: Eli Lilly and Company)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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Reclutamiento

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Federación Rusa
Taipei Medical University Hospital

Reclutamiento

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Reclutamiento

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Grecia
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Terminado

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Porcelana
Cairo University

Terminado

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Egipto
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Estados Unidos

Ensayos clínicos sobre LY2452473

Eli Lilly and Company

Terminado

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Voluntarios Saludables

Estados Unidos
Dana-Farber Cancer Institute
National Institute of Nursing Research (NINR)

Terminado

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Estados Unidos
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Terminado

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Disfuncion erectil

Estados Unidos

A Study of LY900010 in Erectile Dysfunction

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

Descripción general del estudio

Estado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Inscripción (Actual)

Fase

Contactos y Ubicaciones

Ubicaciones de estudio

Criterios de participación

Criterio de elegibilidad

Edades elegibles para estudiar

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Descripción

Plan de estudios

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de brazos

Armas e Intervenciones

Grupo de participantes/brazo

Intervención / Tratamiento

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado

Medida Descripción

Periodo de tiempo

Medidas de resultado secundarias

Medida de resultado

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