Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
15 de dezembro de 2010 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
217
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bad Wiessee, Alemanha, D-83707
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Berlin, Alemanha, 13465
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Hamburg, Alemanha, 20354
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Koblenz, Alemanha, D-56068
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Leipzig, Alemanha, 04109
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Aravaca, Espanha, 28023
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Barcelona, Espanha, 08025
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Madrid, Espanha, 28040
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Majadahonda, Espanha, 28222
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Athens, Grécia, 11527
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Patras, Grécia, 26500
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Thessaloniki, Grécia, 56429
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Catania, Itália, 95100
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Firenze, Itália, 50139
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L Aquila, Itália, 67100
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Milano, Itália, 20132
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Rome, Itália, 00100
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Bialystok, Polônia, 15-223
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Legionowo, Polônia, 05-120
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Lodz, Polônia, 91-425
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Warsaw, Polônia, 00-631
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Placebo
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tablet administered orally once a day for 12 weeks.
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Experimental: Tadalafila
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5 milligrams (mg) administered orally once a day for 12 weeks
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: 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
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2009
Conclusão Primária (Real)
1 de janeiro de 2010
Conclusão do estudo (Real)
1 de janeiro de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
2 de fevereiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de fevereiro de 2009
Primeira postagem (Estimativa)
4 de fevereiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
4 de janeiro de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de dezembro de 2010
Última verificação
1 de dezembro de 2010
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 12229 (Company Internal)
- H6D-MC-LVHX (Outro identificador: Eli Lilly and Company)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em tadalafil
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Institute for the Study of Urological Diseases,...Recrutamento
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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 e outros colaboradoresRecrutamentoHipertensão Arterial Pulmonar (HAP)China
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Cedars-Sinai Medical CenterConcluídoDistrofia Muscular de DuchenneEstados Unidos
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Saint Petersburg State University, RussiaRecrutamento
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Assiut UniversityAinda não está recrutando
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Rambam Health Care CampusDesconhecido
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Eli Lilly and CompanyConcluídoDisfunção erétilAlemanha, Espanha, Estados Unidos, Austrália, Brasil, Itália, México, Porto Rico, Reino Unido
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ActelionConcluídoHipertensão Arterial Pulmonar (HAP) (OMS Grupo 1 HP)Estados Unidos, Japão, Taiwan, Canadá, China, Alemanha, Espanha, Itália, Malásia, Brasil, Hungria, Austrália, Bulgária, México, Polônia, África do Sul, Turquia (Türkiye), Rússia, Tcheca
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Humanis Saglık Anonim SirketiConcluído