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A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

25 mai 2017 mis à jour par: Eli Lilly and Company

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Efficacy and Safety of Tadalafil Once-Daily Dosing for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia and Erectile Dysfunction

The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

909

Phase

  • Phase 3

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

  • Chine
      • Beijing, Chine, 100020
        • 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.
      • Changchun, Chine, 130021
        • 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.
      • Changsha, Chine, 410011
        • 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.
      • Chengdu, Chine, 610072
        • 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.
      • Chongqing, Chine, 400038
        • 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.
      • Hangzhou, Chine, 310003
        • 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.
      • Hefei, Chine, 230022
        • 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.
      • Nanchang, Chine
        • 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.
      • Nanjing, Chine, 210008
        • 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.
      • Shanghai, Chine, 200040
        • 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.
      • Suzhou, Chine, 215006
        • 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.
      • Wenzhou, Chine, 325035
        • 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.
      • Wu Han, Chine, 430030
        • 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.
      • Xi'An, Chine, 710004
        • 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.

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

45 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

Main Inclusion Criteria:

  • Present with a history of ED and signs and symptoms of BPH.
  • Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.

Main Exclusion Criteria:

  • Current treatment with nitrates.
  • Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
  • PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist
  • Suffering from other urinary disease like cancer, or infection
  • Serious cardiovascular disease
  • History of significant renal insufficiency

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
Comparateur placebo: Placebo
Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
Médicament: Placebo
Administré par voie orale
Expérimental: 5 mg Tadalafil

Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.

Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period
Médicament: Placebo
Administré par voie orale
Médicament: 5 mg Tadalafil
Administered orally
Autres noms:
  • LY450190
Autre: 0.2 mg Tamsulosin

Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.

Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period
Médicament: Placebo
Administré par voie orale
Médicament: 0.2 mg Tamsulosin
Administered orally

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
Délai: Baseline, Week 12
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question was scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12
Délai: Baseline, Week 12
IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction 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(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12
Délai: Baseline, Week 12
Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score was determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12
Délai: Baseline, Week 12
Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?".The SEP Q3 score is determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in IPSS at Week 12
Délai: Baseline, Week 12
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM).The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline Erectile dysfunction (ED) severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in Uroflowmetry Measures at Week 12
Délai: Baseline, Week 12

Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter).

At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group.
Baseline, Week 12
Change From Baseline in Postvoid Residual Volume (PVR) at Week 12
Délai: Baseline, Week 12
The amount of urine remaining in the bladder after void completion.
Baseline, Week 12
Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12
Délai: Baseline, Week 12
IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.
Baseline, Week 12
Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12
Délai: Baseline, Week 12
IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.
Baseline, Week 12
Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12
Délai: Baseline, Week 12
IPSS QoL assess participant response to the following question:"If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions.
Baseline, Week 12
Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12
Délai: Week 12
PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).
Week 12
Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12
Délai: Week 12
CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).
Week 12
Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12
Délai: Baseline, Week 12
IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in IIEF Intercourse Satisfaction at Week 12
Délai: Baseline, Week 12
IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during 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 ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in IIEF Orgasmic Function at Week 12
Délai: Baseline, Week 12
IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in IIEF Sexual Desire at Week 12
Délai: Baseline, Week 12
IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in IIEF Subscores at Week 12
Délai: Baseline, Week 12
IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 12
Change From Baseline in Total IPSS at Week 4 and Week 8
Délai: Baseline, Week 4; Baseline, Week 8
IPSS Total Score is the sum of Questions 1 through 7 of the IPSS questionnaire. Each question is scored from 0 (none/no symptoms) to 5 (frequent symptoms) for an IPSS Total Score ranging from 0 to 35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 4; Baseline, Week 8
Change From Baseline in IIEF EF at Week 4 and Week 8
Délai: Baseline, Week 4; Baseline, Week 8
IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.
Baseline, Week 4; Baseline, Week 8
Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8
Délai: Baseline, Week 4; Baseline, Week 8
Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score is determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.
Baseline, Week 4; Baseline, Week 8
Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8
Délai: Baseline, Week 4; Baseline, Week 8
Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?". The SEP Q3 score is determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.
Baseline, Week 4; Baseline, Week 8
Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2
Délai: Baseline, Week 2
The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.
Baseline, Week 2

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

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 septembre 2013

Achèvement primaire (Réel)

1 décembre 2015

Achèvement de l'étude (Réel)

1 décembre 2015

Dates d'inscription aux études

Première soumission

4 septembre 2013

Première soumission répondant aux critères de contrôle qualité

4 septembre 2013

Première publication (Estimation)

10 septembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 juin 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 mai 2017

Dernière vérification

1 mai 2017

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 14393
  • H6D-MC-LVJE (Autre identifiant: Eli Lilly and Company)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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 .

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