A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
25 maggio 2017 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
909
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Beijing, Cina, 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.
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Changchun, Cina, 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.
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Changsha, Cina, 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.
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Chengdu, Cina, 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.
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Chongqing, Cina, 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.
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Hangzhou, Cina, 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.
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Hefei, Cina, 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.
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Nanchang, Cina
- 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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Nanjing, Cina, 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.
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Shanghai, Cina, 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.
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Suzhou, Cina, 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.
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Wenzhou, Cina, 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.
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Wu Han, Cina, 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.
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Xi'An, Cina, 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.
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
45 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
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Somministrato per via orale
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Sperimentale: 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 |
Somministrato per via orale
Administered orally
Altri nomi:
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Altro: 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 |
Somministrato per via orale
Administered orally
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IPSS at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in Uroflowmetry Measures at Week 12
Lasso di tempo: Baseline, Week 12
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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
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Change From Baseline in Postvoid Residual Volume (PVR) at Week 12
Lasso di tempo: Baseline, Week 12
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The amount of urine remaining in the bladder after void completion.
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Baseline, Week 12
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Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12
Lasso di tempo: Week 12
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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).
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Week 12
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Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12
Lasso di tempo: Week 12
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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).
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Week 12
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Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IIEF Intercourse Satisfaction at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IIEF Orgasmic Function at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IIEF Sexual Desire at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in IIEF Subscores at Week 12
Lasso di tempo: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline in Total IPSS at Week 4 and Week 8
Lasso di tempo: Baseline, Week 4; Baseline, Week 8
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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.
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Baseline, Week 4; Baseline, Week 8
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Change From Baseline in IIEF EF at Week 4 and Week 8
Lasso di tempo: Baseline, Week 4; Baseline, Week 8
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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.
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Baseline, Week 4; Baseline, Week 8
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Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8
Lasso di tempo: Baseline, Week 4; Baseline, Week 8
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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.
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Baseline, Week 4; Baseline, Week 8
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Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8
Lasso di tempo: Baseline, Week 4; Baseline, Week 8
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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.
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Baseline, Week 4; Baseline, Week 8
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Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2
Lasso di tempo: Baseline, Week 2
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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.
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Baseline, Week 2
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2013
Completamento primario (Effettivo)
1 dicembre 2015
Completamento dello studio (Effettivo)
1 dicembre 2015
Date di iscrizione allo studio
Primo inviato
4 settembre 2013
Primo inviato che soddisfa i criteri di controllo qualità
4 settembre 2013
Primo Inserito (Stima)
10 settembre 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 giugno 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 maggio 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Disordini mentali
- Processi patologici
- Malattie della prostata
- Disfunzioni sessuali, psicologiche
- Disfunzione sessuale, fisiologica
- Iperplasia prostatica
- Iperplasia
- Disfunzione erettile
- Effetti fisiologici delle droghe
- Antagonisti adrenergici
- Agenti adrenergici
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti vasodilatatori
- Agenti urologici
- Inibitori enzimatici
- Inibitori della fosfodiesterasi
- Inibitori della fosfodiesterasi 5
- Antagonisti del recettore adrenergico alfa-1
- Alfa-antagonisti adrenergici
- Tadalafil
- Tamsulosina
Altri numeri di identificazione dello studio
- 14393
- H6D-MC-LVJE (Altro identificatore: Eli Lilly and Company)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .