A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
25 mei 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
909
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Beijing, China, 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, China, 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, China, 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, China, 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, China, 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, China, 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, China, 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, China
- 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, China, 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, China, 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, China, 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, China, 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, China, 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, China, 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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
45 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Placebo-vergelijker: Placebo
Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
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Oraal toegediend
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Experimenteel: 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 |
Oraal toegediend
Administered orally
Andere namen:
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Ander: 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 |
Oraal toegediend
Administered orally
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2013
Primaire voltooiing (Werkelijk)
1 december 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
4 september 2013
Eerst ingediend dat voldeed aan de QC-criteria
4 september 2013
Eerst geplaatst (Schatting)
10 september 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
20 juni 2017
Laatste update ingediend die voldeed aan QC-criteria
25 mei 2017
Laatst geverifieerd
1 mei 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Psychische aandoening
- Pathologische processen
- Prostaat Ziekten
- Seksuele disfuncties, psychisch
- Seksuele disfunctie, fysiologisch
- Prostaathyperplasie
- Hyperplasie
- Erectiestoornissen
- Fysiologische effecten van medicijnen
- Adrenerge antagonisten
- Adrenerge middelen
- Neurotransmitter agenten
- Moleculaire mechanismen van farmacologische werking
- Vaatverwijdende middelen
- Urologische middelen
- Enzymremmers
- Fosfodiësteraseremmers
- Fosfodiësterase 5-remmers
- Adrenerge alfa-1-receptorantagonisten
- Adrenerge alfa-antagonisten
- Tadalafil
- Tamsulosine
Andere studie-ID-nummers
- 14393
- H6D-MC-LVJE (Andere identificatie: Eli Lilly and Company)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
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