A Study of Tadalafil After Radical Prostatectomy (REACTT)
12 décembre 2013 mis à jour par: Eli Lilly and Company
A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy
The study will include patients with localized prostate cancer who experience erectile dysfunction following bilateral nerve-sparing radical prostatectomy.
Patients will be randomly assigned to three treatment arms: Tadalafil 5 mg once a day, Tadalafil 20 mg on demand (prior to anticipated sexual activity), and placebo.
Patients will stay on therapy for 9 months and after withdrawal of medication for 6 weeks, patients will be evaluated for recovery of unassisted erectile function (without medication).
An open-label extension for three months will evaluate the responsiveness of all patients to Tadalafil 5 mg once a day.
Further objectives are to evaluate the treatment satisfaction of the respective therapies.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
583
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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Berlin, Allemagne, 12203
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Braunschweig, Allemagne, 38126
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Dresden, Allemagne, 01307
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Essen, Allemagne, 45122
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Hamburg, Allemagne, 20246
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Hannover, Allemagne, 30625
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Herne, Allemagne, 44627
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Leipzig, Allemagne, 04103
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Leverkusen, Allemagne, 51375
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Kortrijk, Belgique, 8500
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Leuven, Belgique, 3000
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Liège, Belgique, 4000
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Alberta
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Calgary, Alberta, Canada, T2W 1P9
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British Columbia
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Victoria, British Columbia, Canada, V8T 5G1
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Ontario
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London, Ontario, Canada, N6A 4V2
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Aravaca, Espagne, 28023
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Cordoba, Espagne, 14004
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Madrid, Espagne, 28046
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Majadahonda, Espagne, 28222
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Málaga, Espagne, 29010
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Sevilla, Espagne, 41013
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Valencia, Espagne, 46010
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Creteil, France, 94010
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Grenoble, France, 38043
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Lyon, France, 69437
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Nice, France, 06002
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Nimes, France, 30029
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Pierre Benite, France, 69495
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Acquavivadellefonti, Italie, 70021
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Bergamo, Italie, 24128
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Bologna, Italie, 40138
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Genova, Italie, 16132
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Milano, Italie, 20132
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Perugia, Italie, 06122
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Amsterdam, Pays-Bas, 1066 CX
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Leiden, Pays-Bas, 2300 RC
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Nijmegen, Pays-Bas, 6532 SZ
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Rotterdam, Pays-Bas, 3045 PM
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S-Hertogenbosch, Pays-Bas, 5211 NL
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Veldhoven, Pays-Bas, 5504 DB
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Bydgoszcz, Pologne, 85-168
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Gdansk, Pologne, 80-952
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Kielce, Pologne, 25-734
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Warsaw, Pologne, 02-005
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Zabrze, Pologne, 41-800
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Cambridgeshire
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Cambridge, Cambridgeshire, Royaume-Uni, CB2 0QQ
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Cleveland
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Middlesbrough, Cleveland, Royaume-Uni, TS4 3BW
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Herts
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Stevenage, Herts, Royaume-Uni, SG4 7NH
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Manchester
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Withington, Manchester, Royaume-Uni, M20 9BX
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Basel, Suisse, CH-4031
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Luzern, Suisse, CH-6000
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Zurich, Suisse, CH-8091
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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 à 67 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
La description
Inclusion Criteria:
- scheduled to undergo Bilateral nerve-sparing radical prostatectomy (BNSRP) for organ-confined, non-metastatic prostate cancer
- have a normal preoperative erectile function score of more or equal to 22 at screening(as evaluated by International Index of Erectile Function - Erectile Function domain (IIEF-EF))
- develop Erectile Dysfunction (ED) (defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) after surgery
- have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study
- agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
- does not require the initiation of adjuvant therapy for prostate cancer
Exclusion Criteria:
- history of ED
- have received previous or current treatment with tadalafil or any other Phosphodiesterase Type 5 (PDE5) inhibitor
- have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer
- have a history of prostatic surgery or prostatic physical treatments
- have a history of diabetes mellitus
- have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption
- have clinically significant renal insufficiency as determined by the investigator
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: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Tadalafil daily [5 milligrams (mg)]
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
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Administered by mouth for 9 months
Autres noms:
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Expérimental: Tadalafil on demand (20 mg)
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
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Administered by mouth for 9 months
Autres noms:
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Comparateur placebo: Placebo
After the treatment period and 6-week study Drug-Free Period, all participants can continue on study in an optional 5-mg tadalafil 3-month Open-Label Period.
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Administered by mouth, daily or on demand for 9 months
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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 With a Score of Greater Than or Equal to 22 in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire
Délai: Month 10.5
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Self-reported erectile function during the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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 with an IIEF-EF Total Score greater than or equal to (≥) 22.
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Month 10.5
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of Participants With a Score of Greater Than or Equal to 22 in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain
Délai: Month 9 and Month 13.5
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Self-reported erectile function during the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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 with an IIEF-EF Total Score greater than or equal to (≥) 22.
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Month 9 and Month 13.5
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Change From Baseline to Endpoint in the International Index of Erectile Function- Erectile Function (IIEF-EF) Total Score
Délai: Randomization (Baseline), Months 9 and 10.5 and 13.5
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Self-reported erectile function during the past 4 weeks.
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF.
Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) 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.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for baseline score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 10.5 and 13.5
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Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF) Domains (Intercourse Satisfaction Domain, Orgasmic Function Domain, Sexual Desire Domain, Overall Satisfaction Domain)
Délai: Randomization (Baseline), Months 9 and 10.5 and 13.5
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Self-reported overall satisfaction during past 4 weeks.
Orgasmic function score is sum of Questions (Q)9 and 10 of IIEF.
Scores range from 0 (no sexual stimulation or intercourse) to 5 (high orgasm) for each Q, total 0 to 10. Sexual desire score is sum of Q11 and 12 of IIEF.
Scores range from 1 (low/no desire) to 5 (high desire) for each Q, total 2 to 10. Intercourse satisfaction score is sum of Q6, 7 and 8 of IIEF.
Scores range from 0 (no attempts for Q6, did not attempt intercourse for Q7 and no intercourse for Q8) to 5 (high satisfaction) for each Q, total 0 to 15. Overall satisfaction score is sum of Q13 and 14 of IIEF.
Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each Q, total 2 to 10. Higher total scores for each domain indicate higher function.
MMRM analysis was used to calculate LS mean and 95% CI.
LS mean values are adjusted for baseline, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 10.5 and 13.5
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Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire Mean Score
Délai: Months 9 and 13.5
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The EDITS questionnaire is a validated questionnaire consisting of 11 questions evaluating self-reported satisfaction with the erectile dysfunction (ED) treatment.
Responses were based on the experiences during the previous 4 weeks.
Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction).
The EDITS mean score was obtained by adding each individual result for all questions, dividing by the number of questions answered.
The mean scores range from 0 (extremely low treatment satisfaction) to 4 (extremely high satisfaction).
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI).
LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Months 9 and 13.5
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Change From Baseline in Self Esteem and Relationship (SEAR) Questionnaire Score
Délai: Randomization (Baseline), Months 9 and 13.5
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The SEAR questionnaire is a participant-reported measure of psychosocial outcomes in men with erectile dysfunction (ED).
It consists of 14 items.
Sexual Relationship domain consists of 8 items (items 1-8).
Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never).
The total scores for sexual relationship domain range from 8-40 with higher scores indicating better relationship.
Self-Esteem subdomain contains items 9 through 12 rated on a scale of 1 (no/low self-esteem) to 5 (high self-esteem).
Total scores for Self-Esteem subscale range from 4-20 with higher scores indicating higher self-esteem.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% Confidence Interval (CI).
LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 13.5
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Global Assessment Questions (GAQ) Question 1 at Month 9
Délai: Month 9
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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 very much better (1) to very much worse (7).
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Month 9
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Global Assessment Question (GAQ) Question 1 at Month 13.5
Délai: Month 13.5
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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 very much better (1) to very much worse (7).
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Month 13.5
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Global Assessment Question (GAQ) Question 2 at Month 9
Délai: Month 9
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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 very much better (1) to very much worse (7).
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Month 9
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Global Assessment Question (GAQ) Question 2 at Month 13.5
Délai: Month 13.5
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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 very much better (1) to very much worse (7).
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Month 13.5
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Residual Erectile Function (REF) at Baseline
Délai: Baseline
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Baseline
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Residual Erectile Function (REF) at Month 2
Délai: Month 2
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 2
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Residual Erectile Function (REF) at Month 5
Délai: Month 5
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 5
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Residual Erectile Function (REF) at Month 9
Délai: Month 9
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 9
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Residual Erectile Function (REF) at Month 10.5
Délai: Month 10.5
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 10.5
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Residual Erectile Function (REF) at Month 13.5
Délai: Month 13.5
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The participant is asked to rate the hardness of his erection using a 5-point grading system, with 0 (penis does not enlarge), 1 (penis is larger but not hard), 2 (penis is hard but not enough for penetration), 3 (penis is hard enough for penetration but not completely hard), 4 (penis is completely hard and fully rigid.)
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Month 13.5
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Change From Baseline in 'Yes' Answers to Questions 1 to 5 of the Sexual Encounter Profile (SEP)
Délai: Randomization (Baseline), Months 9 and 10.5 and 13.5
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Participant-assessed diary has 5 questions: Question (Q)1: 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-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 10.5 and 13.5
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Change From Baseline in 'Yes' Answers to Morning Erections
Délai: Randomization (Baseline), Month 10.5
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The participants were asked to complete the morning erections diary every morning during the 4-week period before randomization and during the 6-week, Drug-Free, Washout Period.
Data presented are the changes in the participant's percentage of "yes" responses relative to the number of days the question was answered during treatment.
The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for treatment, baseline morning erections frequency, age group and country.
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Randomization (Baseline), Month 10.5
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Standardized Morning Erections Question (SMEQ) Score at Month 2
Délai: Month 2
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Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
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Month 2
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Standardized Morning Erections Question (SMEQ) Score at Month 9
Délai: Month 9
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Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
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Month 9
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Standardized Morning Erections Question (SMEQ) Score at Month 13.5
Délai: Month 13.5
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Participants evaluated the frequency of their morning erections during the past 3-month period by answering the SMEQ ("Do you ever wake up with an erection") using a 4-point grading system ranging from 0 (Yes, regularly) to 3 (never).
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Month 13.5
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Change From Baseline in 26-item Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire Score
Délai: Randomization (Baseline), Months 9 and 13.5
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EPIC-26 (participants) contains 26 items and 5 domains: Urinary Incontinence (Items 1-4), Urinary Irritative/Obstructive (Items 5-8), Bowel (Items 10-15), Sexual (Items 16-21), and Hormonal (Items 22-26).
Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0 to 100 scale for each domain, with higher scores representing better health-related quality of life.
Responses are based on experiences during the previous 4 weeks.
The Mixed Model for Repeated Measures (MMRM) analysis was used to calculate Least Squares (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for baseline domain score, treatment, country, visit, visit-by-treatment, age group, and age group-by-treatment (if significant at p<0.10).
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Randomization (Baseline), Months 9 and 13.5
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Change in Penile Length and Girth
Délai: Randomization (Baseline), Month 9
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Measurements were performed with the penis in the flaccid state.
The stretched penile length was measured from the tip of the glans to the pubopenile skin junction while applying tension to maximally stretch the penis.
The penile circumference at midshaft was measured.
All measurements were taken with a paper ruler to the nearest 0.5 centimeter (cm).
The analysis of covariance (ANCOVA) was used to calculate Least Square (LS) mean and 95% confidence interval (CI).
LS mean values are adjusted for treatment, baseline, age group and country.
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Randomization (Baseline), Month 9
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Collaborateurs et enquêteurs
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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
- Montorsi F, Oelke M, Henneges C, Brock G, Salonia A, d'Anzeo G, Rossi A, Mulhall JP, Buttner H. Exploratory Decision-Tree Modeling of Data from the Randomized REACTT Trial of Tadalafil Versus Placebo to Predict Recovery of Erectile Function After Bilateral Nerve-Sparing Radical Prostatectomy. Eur Urol. 2016 Sep;70(3):529-37. doi: 10.1016/j.eururo.2016.02.036. Epub 2016 Mar 3.
- Patel HR, Ilo D, Shah N, Cuzin B, Chadwick D, Andrianne R, Henneges C, Barry J, Hell-Momeni K, Branicka J, Buttner H. Effects of tadalafil treatment after bilateral nerve-sparing radical prostatectomy: quality of life, psychosocial outcomes, and treatment satisfaction results from a randomized, placebo-controlled phase IV study. BMC Urol. 2015 Apr 12;15:31. doi: 10.1186/s12894-015-0022-9.
- Montorsi F, Brock G, Stolzenburg JU, Mulhall J, Moncada I, Patel HR, Chevallier D, Krajka K, Henneges C, Dickson R, Buttner H. Effects of tadalafil treatment on erectile function recovery following bilateral nerve-sparing radical prostatectomy: a randomised placebo-controlled study (REACTT). Eur Urol. 2014 Mar;65(3):587-96. doi: 10.1016/j.eururo.2013.09.051. Epub 2013 Oct 13.
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 novembre 2009
Achèvement primaire (Réel)
1 octobre 2012
Achèvement de l'étude (Réel)
1 octobre 2012
Dates d'inscription aux études
Première soumission
3 décembre 2009
Première soumission répondant aux critères de contrôle qualité
3 décembre 2009
Première publication (Estimation)
4 décembre 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
14 janvier 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 décembre 2013
Dernière vérification
1 décembre 2013
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
- 13086
- H6D-EW-LVIK (Autre identifiant: Eli Lilly and Company)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .