- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01130532
A Study in Erectile Dysfunction
3 décembre 2012 mis à jour par: Eli Lilly and Company
Tadalafil Once Daily Following As-Needed Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function
The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
623
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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British Columbia
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Langley, British Columbia, Canada, V3A 4H9
- 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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Victoria, British Columbia, Canada, V8T 5G1
- 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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Ontario
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Burlington, Ontario, Canada, L7N 3V2
- 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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North York, Ontario, Canada, M3B 3S6
- 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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Quebec
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Montreal, Quebec, Canada, H2X 1N8
- 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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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 7H9
- 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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Alabama
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Huntsville, Alabama, États-Unis, 35801
- 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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California
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Lancaster, California, États-Unis, 93534
- 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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Newport Beach, California, États-Unis, 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.
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San Diego, California, États-Unis, 92103
- 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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Spring Valley, California, États-Unis, 91978
- 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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Tarzana, California, États-Unis, 91356
- 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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Connecticut
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New Britain, Connecticut, États-Unis, 06052
- 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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Florida
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Aventura, Florida, États-Unis, 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.
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Fort Lauderdale, Florida, États-Unis, 33316
- 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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Oviedo, Florida, États-Unis, 32765
- 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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Idaho
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Meridian, Idaho, États-Unis, 83646
- 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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Nampa, Idaho, États-Unis, 83686
- 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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Kansas
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Lansing, Kansas, États-Unis, 66043
- 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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Topeka, Kansas, États-Unis, 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.
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Massachusetts
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Haverhill, Massachusetts, États-Unis, 01830
- 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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Michigan
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Troy, Michigan, États-Unis, 48085
- 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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New Jersey
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Toms River, New Jersey, États-Unis, 08753
- 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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New York
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Garden City, New York, États-Unis, 11530
- 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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Poughkeepsie, New York, États-Unis, 12601
- 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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North Carolina
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Concord, North Carolina, États-Unis, 28025
- 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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Wilmington, North Carolina, États-Unis, 28401
- 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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North Dakota
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Fargo, North Dakota, États-Unis, 58103
- 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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Ohio
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Lyndhurst, Ohio, États-Unis, 44124
- 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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Pennsylvania
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Bala Cynwyd, Pennsylvania, États-Unis, 19004
- 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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South Carolina
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Anderson, South Carolina, États-Unis, 29621
- 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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Greer, South Carolina, États-Unis, 29651
- 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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Mt. Pleasant, South Carolina, États-Unis, 29464
- 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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Tennessee
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Knoxville, Tennessee, États-Unis, 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.
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Texas
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Austin, Texas, États-Unis, 78731
- 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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San Antonio, Texas, États-Unis, 78258
- 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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Utah
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Clinton, Utah, États-Unis, 84015
- 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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Washington
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Bellevue, Washington, États-Unis, 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.
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Seattle, Washington, États-Unis, 98166
- 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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Spokane, Washington, États-Unis, 99220
- 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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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- At least a 3-month history of erectile dysfunction (ED).
- Are able to read, understand and provide signed informed consent.
- Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
- Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
- Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
- Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
- Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.
Partner Inclusion Criteria:
- Are female and at least 18 years of age at screening.
- Anticipate having the same male study subject as her sexual partner during the study.
- Able to read, understand and provide signed informed consent.
- Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
- Willing to participate in recording responses to the treatment satisfaction scale.
Exclusion Criteria:
- Have an IIEF-EF domain score of greater than or equal to 26 at screening.
- Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
- Have previously used or are currently using any PDE5 inhibitor once daily.
- Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
- Partner unwilling to complete all study requirements.
- History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
- Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
- Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
- Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur placebo: Placebo
pendant 12 semaines
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Administer orally
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Comparateur actif: 2.5 milligram (mg) titrated to 5 mg Tadalafil
2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks
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Administer orally
Autres noms:
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Comparateur actif: 5 mg Tadalafil
5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks
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Administer orally
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)
Délai: Baseline through 12 weeks
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Self-reported erectile function over the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).
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Baseline through 12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Délai: Baseline, 12 weeks
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Self-reported erectile function over the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score
Délai: Baseline, 12 weeks
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Self-reported intercourse satisfaction over the past 4 weeks.
IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF.
Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score
Délai: Baseline, 12 weeks
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Self-reported overall satisfaction over the past 4 weeks.
IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Délai: Baseline, 12 weeks
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Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5.
Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Délai: Baseline, 12 weeks
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The TSS measured participant satisfaction with treatment based on a 13-item questionnaire.
The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction.
Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint
Délai: Week 12
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The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire.
The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction.
Satisfaction with medication was analyzed using analysis of covariance (ANOVA).
The model included factors of study, treatment group, and pooled site within study.
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Week 12
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Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)
Délai: Baseline, 12 weeks
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Self-reported erectile function over the past 4 weeks.
Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence).
Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Délai: Baseline, 12 weeks
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The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire.
The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction.
Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA).
The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
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Baseline, 12 weeks
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Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint
Délai: Week 12
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The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire.
The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction.
Satisfaction with medication was analyzed using analysis of covariance (ANOVA).
The model included factors of study, treatment group, and pooled site within study.
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Week 12
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Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks
Délai: 12 weeks through 16 weeks
|
Self-reported erectile function over the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of open-label extension treatment period (Period IV).
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12 weeks through 16 weeks
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Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
Délai: 12 weeks and 16 weeks
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Self-reported erectile function over the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30.
Higher scores represent better erectile function.
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12 weeks and 16 weeks
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Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3
Délai: 12 weeks and 16 weeks
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Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?"
from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).
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12 weeks and 16 weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Kim E, Seftel A, Goldfischer E, Baygani S, Burns P. Comparative efficacy of tadalafil once daily in men with erectile dysfunction who demonstrated previous partial responses to as-needed sildenafil, tadalafil, or vardenafil. Curr Med Res Opin. 2015 Feb;31(2):379-89. doi: 10.1185/03007995.2014.989317. Epub 2014 Dec 2.
- Kim ED, Seftel AD, Goldfischer ER, Ni X, Burns PR. A return to normal erectile function with tadalafil once daily after an incomplete response to as-needed PDE5 inhibitor therapy. J Sex Med. 2014 Mar;11(3):820-30. doi: 10.1111/jsm.12253. Epub 2013 Jul 10.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 août 2010
Achèvement primaire (Réel)
1 janvier 2012
Achèvement de l'étude (Réel)
1 janvier 2012
Dates d'inscription aux études
Première soumission
24 mai 2010
Première soumission répondant aux critères de contrôle qualité
24 mai 2010
Première publication (Estimation)
26 mai 2010
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
4 janvier 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 décembre 2012
Dernière vérification
1 décembre 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Dysfonctions sexuelles, psychologiques
- Dysfonction sexuelle, physiologique
- Dysérection
- Mécanismes moléculaires de l'action pharmacologique
- Agents vasodilatateurs
- Agents urologiques
- Inhibiteurs d'enzymes
- Inhibiteurs de la phosphodiestérase
- Inhibiteurs de la phosphodiestérase 5
- Tadalafil
Autres numéros d'identification d'étude
- 13461 (UKCRN)
- H6D-US-LVIP (Autre identifiant: Eli Lilly and Company)
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