Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
15 de diciembre de 2010 actualizado por: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors.
Patients may be dose reduced to 2.5mg based on tolerability.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
217
Fase
- Fase 3
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
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Bad Wiessee, Alemania, D-83707
- 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.
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Berlin, Alemania, 13465
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Hamburg, Alemania, 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.
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Koblenz, Alemania, D-56068
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Leipzig, Alemania, 04109
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Aravaca, España, 28023
- 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.
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Barcelona, España, 08025
- 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.
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Madrid, España, 28040
- 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.
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Majadahonda, España, 28222
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Athens, Grecia, 11527
- 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.
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Patras, Grecia, 26500
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Thessaloniki, Grecia, 56429
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Catania, Italia, 95100
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Firenze, Italia, 50139
- 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.
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L Aquila, Italia, 67100
- 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.
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Milano, Italia, 20132
- 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.
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Rome, Italia, 00100
- 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.
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Bialystok, Polonia, 15-223
- 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.
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Legionowo, Polonia, 05-120
- 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.
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Lodz, Polonia, 91-425
- 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.
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Warsaw, Polonia, 00-631
- 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.
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- You are male and aged at least 18 years.
- Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
- Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
- You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
- Your entry laboratory test results and medical tests meet study requirements
- You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
- If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.
Exclusion Criteria:
- You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
- Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
- You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
- Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
- Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
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
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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tablet administered orally once a day for 12 weeks.
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Experimental: Tadalafilo
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5 milligrams (mg) administered orally once a day for 12 weeks
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Periodo de tiempo: Baseline, Week 12
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Self-reported erectile function over the past 4 weeks.
Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF).
Total Erectile Function Domain scores range from 0 to 30.
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Baseline, Week 12
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Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Periodo de tiempo: Baseline, Week 12
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. "Were you able to insert your penis into your partner's vagina?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, Week 12
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Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses
Periodo de tiempo: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. "Did your erection last long enough for you to have successful intercourse?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
Periodo de tiempo: Baseline, Week 12
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NPT was measured using electrobioimpedance volumetric assessment (NEVA).
The NEVA device measures a man's erections during the night.
The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up).
Data are entered for the 2 nights prior to the visit.
During the night the man may have multiple erections.
The number of erections is recorded.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
Periodo de tiempo: Baseline, Week 12
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NPT was measured using electrobioimpedance volumetric assessment (NEVA).
The NEVA device measures a man's erections during the night.
The duration of erections are measured and recorded.
Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
Periodo de tiempo: Baseline, Week 12
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NPT was measured using electrobioimpedance volumetric assessment (NEVA).
The NEVA device measures a man's erections during the night.
The percent of volume change of the penis during erections is measured and recorded for each erection.
Data presented are mean percentage of volumetric change from baseline to Week 12.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
Periodo de tiempo: Baseline, 12 weeks
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The morning erection diary allows the participant to record whether he experienced an erection on waking.
The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods.
The percentage of mornings the participant reported an erection is analysed.
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Baseline, 12 weeks
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The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
Periodo de tiempo: Week 12
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The subject questionnaire consists of 11 questions.
Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction).
The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).
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Week 12
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Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
Periodo de tiempo: Baseline, Week 12
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SEAR measures improvement in self-esteem and relationship satisfaction.
Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14).
All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always.
Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items.
Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
Periodo de tiempo: Baseline, Week 12
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Self-reported overall satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
Periodo de tiempo: Baseline, 12 weeks
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Self-reported overall satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
Periodo de tiempo: Baseline, Week 12
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Self-reported intercourse satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
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Baseline, Week 12
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Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
Periodo de tiempo: Baseline, 12 weeks
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Self-reported overall satisfaction over the past 4 weeks.
Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of "Yes" Responses
Periodo de tiempo: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. "Were you able to achieve at least some erection (some enlargement of the penis)?
" Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of "Yes" Responses
Periodo de tiempo: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. "Were you satisfied with the hardness of your erection?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of "Yes" Responses
Periodo de tiempo: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. "Were you satisfied overall with this sexual experience?"
Data are presented as the mean percentage of yes responses per participant.
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Baseline, 12 weeks
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Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
Periodo de tiempo: Week 12
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GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study.
Responses range from 1=very much better to 7=very much worse.
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Week 12
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Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
Periodo de tiempo: Week 12
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GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study.
Responses range from 1=very much better to 7=very much worse.
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Week 12
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Call 1-877-CTLILLY(1-877-285-459) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM eastern time (UTC/GMT -5 hours, EST), Eli Lilly and Company
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
- Porst H, Brock GB, Kula K, Moncada I, Montorsi F, Basson BR, Kinchen K, Aversa A. Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors. J Androl. 2012 Nov-Dec;33(6):1305-22. doi: 10.2164/jandrol.111.015289. Epub 2012 Jul 12.
- Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naive to PDE5 inhibitors. J Sex Med. 2011 Sep;8(9):2617-24. doi: 10.1111/j.1743-6109.2011.02353.x. Epub 2011 Jun 27.
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 enero de 2009
Finalización primaria (Actual)
1 de enero de 2010
Finalización del estudio (Actual)
1 de enero de 2010
Fechas de registro del estudio
Enviado por primera vez
2 de febrero de 2009
Primero enviado que cumplió con los criterios de control de calidad
3 de febrero de 2009
Publicado por primera vez (Estimar)
4 de febrero de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de enero de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
15 de diciembre de 2010
Última verificación
1 de diciembre de 2010
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 12229 (Company Internal)
- H6D-MC-LVHX (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. .
Ensayos clínicos sobre Disfuncion erectil
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Aspargo Labs, IncAún no reclutando
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Benha UniversityTerminado
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National Scientific Medical Center, KazakhstanMedical Center Medi-ArtActivo, no reclutando
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University of California, San FranciscoReclutamientoDisfuncion erectilEstados Unidos
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Pharmicell Co., Ltd.ReclutamientoDisfuncion erectilCorea del Sur
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Nabiqasim Industries (Pvt) LtdPakistan Society of Internal MedicineAún no reclutando
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Aspargo Labs, IncAún no reclutando
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Assiut UniversityAún no reclutando
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South Valley UniversityTerminado
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Menoufia UniversityTerminado
Ensayos clínicos sobre tadalafil
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Second Affiliated Hospital, School of Medicine,...Ningbo Medical Center Lihuili Hospital; Guangdong Provincial People's Hospital; First Affiliated Hospital of Wenzhou Medical University y otros colaboradoresReclutamientoHipertensión Arterial Pulmonar (HAP)Porcelana
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Cedars-Sinai Medical CenterTerminadoDistrofia muscular de DuchenneEstados Unidos
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Assiut UniversityAún no reclutando
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GlaxoSmithKlineHammersmith Medicines Research; Covance HarrogateTerminadoHipertensión PulmonarReino Unido
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Fayoum University HospitalTerminadoBPH con otros síntomas del tracto urinario inferiorEgipto
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Assiut UniversityAún no reclutandoHPB (Hiperplasia Prostática Benigna)
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Ain Shams UniversityTerminadoManejo de luts y dolor relacionados con el stent uretericEgipto
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Kafrelsheikh UniversityTerminado
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HealthCore-NERIMassachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI)TerminadoInsuficiencia cardiaca | Hipertensión pulmonarEstados Unidos, Canadá