A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
25. května 2017 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
909
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Beijing, Čína, 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, Čína, 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, Čína, 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, Čína, 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, Čína, 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, Čína, 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, Čína, 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, Čína
- 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, Čína, 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, Čína, 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, Čína, 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, Čína, 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, Čína, 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, Čína, 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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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
45 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: Placebo
Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
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Podává se ústně
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Experimentální: 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 |
Podává se ústně
Administered orally
Ostatní jména:
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Jiný: 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 |
Podává se ústně
Administered orally
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2013
Primární dokončení (Aktuální)
1. prosince 2015
Dokončení studie (Aktuální)
1. prosince 2015
Termíny zápisu do studia
První předloženo
4. září 2013
První předloženo, které splnilo kritéria kontroly kvality
4. září 2013
První zveřejněno (Odhad)
10. září 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
20. června 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. května 2017
Naposledy ověřeno
1. května 2017
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Duševní poruchy
- Patologické procesy
- Onemocnění prostaty
- Sexuální dysfunkce, psychologické
- Sexuální dysfunkce, fyziologické
- Hyperplazie prostaty
- Hyperplazie
- Erektilní dysfunkce
- Fyziologické účinky léků
- Adrenergní antagonisté
- Adrenergní látky
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Vazodilatační činidla
- Urologická činidla
- Inhibitory enzymů
- Inhibitory fosfodiesterázy
- Inhibitory fosfodiesterázy 5
- Antagonisté adrenergního alfa-1 receptoru
- Adrenergní alfa-antagonisté
- Tadalafil
- Tamsulosin
Další identifikační čísla studie
- 14393
- H6D-MC-LVJE (Jiný identifikátor: Eli Lilly and Company)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
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