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

Primary Purpose

Benign Prostate Hyperplasia, Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

5 mg Tadalafil

Placebo

0.2 mg Tamsulosin

About this trial

This is an interventional treatment trial for Benign Prostate Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Other

Arm Label

Placebo

5 mg Tadalafil

0.2 mg Tamsulosin

Arm Description

Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.

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

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

Outcomes

Primary Outcome Measures

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12

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

Secondary Outcome Measures

Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12

IIEF is a 15 item self-reported questionnaire to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0(low/no erectile function) to 5(high erectile function) and Question 15 is scored 1(very low confidence) to 5(very high confidence) with a total score ranging from 1 to 30.Higher scores represent better erectile function.LS mean of change from baseline to endpoint is from MMRM.The model includes effects for treatment,country/region,baseline lower urinary tract symptoms(LUTS) severity (moderate/severe),visit,treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant-the overall baseline mean value), placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered baseline-by-treatment and treatment-by-country/region interactions.The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12

Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score was determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change is defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.

Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12

Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?".The SEP Q3 score is determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.

Change From Baseline in IPSS at Week 12

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

Change From Baseline in Uroflowmetry Measures at Week 12

Qmax is defined as the peak urine flow rate (measured in milliliters per second [mL/sec] using standard calibrated flowmeter). At each visit, a uroflowmetry assessment was considered valid and the data were included only if the prevoid total bladder volume (assessed by ultrasound) was >=150 to <=550 milliliters (mL) and the voided volume (Vcomp) was >=125 mL. Changes in Qmax from baseline to endpoint in the double-blind treatment period were analyzed using Type III sums of squares ANOVA on rank-transformed data with a term for treatment group.

Change From Baseline in Postvoid Residual Volume (PVR) at Week 12

The amount of urine remaining in the bladder after void completion.

Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12

IPSS Storage (Irritative) subscore is the sum of Questions 2, 4 and 7 of the IPSS questionnaire. Scores ranged from 0 (no irritative symptoms) to 5 (frequent irritative symptoms), with total subscore of the 3 questions for irritative subscore ranging from 0 to 15; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.

Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12

IPSS voiding (obstructive) subscore is the sum of Questions 1, 3, 5 and 6 of the IPSS questionnaire. Scores ranged from 0 (no obstructive symptoms) to 5 (frequent obstructive symptoms), with total subscore of the 4 questions of the obstructive score ranging from 0 to 20; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, prior alpha-blocker therapy, baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions.

Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12

IPSS QoL assess participant response to the following question:"If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". Response options are Delighted(0),Pleased(1);Mostly satisfied(2);mixed about equally satisfied and dissatisfied(3);Mostly dissatisfied(4);Unhappy(5);Terrible(6),with a total ranging from 0 to 6; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares(LS) mean of change from baseline(bl) to endpoint is from MMRM.The model includes effects for treatment,country/region, prior alpha-blocker therapy,baseline ED severity (mild/moderate/severe),visit, treatment-by-visit interaction, centered bl value (defined as the bl value for a participant -the overall bl mean value),placebo lead-in total IPSS change(change from Visit 2 at Visit 3),centered bl-by-treatment and treatment-by-country/region interactions.

Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12

PGI-I measures a participant's perception of improvement at the time of assessment compared with the start of treatment. Score ranges from 1 (very much better) to 7 (very much worse).

Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12

CGI-I measures clinician's perception of participant improvement at the time of assessment (compared with the start of treatment) with scores ranging from 1 (very much better) to 7 (very much worse).

Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14. Scores range from 1 (low/no satisfaction) to 5 (high satisfaction) for each question, with a total subscore ranging from 2 to 10;higher scores represent better erectile function. Least squares (LS) mean of change from baseline to endpoint is from an analysis mixed model for repeated measures (MMRM). The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in IIEF Intercourse Satisfaction at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF-IS is the sum of Questions 6,7 and 8 of the IIEF. Scores range from 0(low/no satisfaction) to 5(high satisfaction) for each question, with the total possible score for the 3 questions ranging from 0 to 15.Higher scores were indicative of an increase in intercourse satisfaction. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction,centered baseline value(defined as the baseline value for a participant- the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in IIEF Orgasmic Function at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF orgasmic function is the sum of Q9 and Q10 of the IIEF. Scores ranged from 0 (no stimulation) to 5 (almost always) for each question, with the total possible score for the 2 questions ranging from 0 to 10. Higher scores were indicative of better orgasmic function. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in IIEF Sexual Desire at Week 12

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF sexual desire is the sum of Q11 and Q12. Scores ranged from 1 (low/almost never) to 5 (very high/almost always) for each question, with the total possible score for the 2 questions ranging from 2 to 10. Higher scores were indicative of increased sexual desire. Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in IIEF Subscores at Week 12

IIEF Question 3 asks how often a participant was able to penetrate his partner over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). IIEF Question 4 asks whether/how often a participant was able to maintain an erection after penetration over the past 4 weeks. Scores range from 0 (did not attempt intercourse) to 5 (almost always or always). Least squares (LS) mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in Total IPSS at Week 4 and Week 8

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

Change From Baseline in IIEF EF at Week 4 and Week 8

IIEF is a 15 item self-reported questionnaire used to assess overall erectile function and satisfaction during the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 were scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 was scored 1 (very low confidence) to 5 (very high confidence) with a total score ranging from 1 to 30. Higher scores represent better erectile function. LS mean of change from baseline to endpoint is from MMRM. The model includes effects for treatment, country/region, baseline LUTS severity (moderate/severe), visit, treatment-by-visit interaction, centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), centered baseline-by-treatment and treatment-by-country/region interactions. The centered baseline-by-treatment and treatment-by-country interactions was removed if p >= 0.10.

Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8

Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q2, "Were you able to insert your penis into your partner's vagina?". The SEP Q2 score is determined as the percentage of "yes" responses to SEP Q2 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus the percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.

Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8

Participant-assessed diary assesses the mean change from baseline in the percentage of "yes" responses to SEP Q3, "Did your erection last long enough for you to have successful intercourse?". The SEP Q3 score is determined as the percentage of "yes" responses to SEP Q3 out of all sexual attempts recorded during the time period. Change was defined as the percentage of "yes" responses at endpoint minus percentage of "yes" responses at baseline. Least squares (LS) mean of change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model includes terms for treatment, country/region, baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.

Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2

The modified IPSS is the total IPSS collected at 2 weeks post-baseline.The total IPSS is obtained by combining the scores of the responses to component questions 1 through 7. Each question is scored from 0-5 for a total IPSS range of 0-35 points; higher numerical scores from the IPSS questionnaire represent greater severity of symptoms. Least squares (LS) mean of change from baseline to endpoint is from ANCOVA. The model includes terms for treatment, country/region, prior alpha-blocker use and baseline ED severity (mild/moderate/severe), centered baseline value (defined as the baseline value for a participant - the overall baseline mean value), placebo lead-in total IPSS change (change from Visit 2 at Visit 3), the centered baseline-by-treatment and the treatment-by-country/region interactions. The interaction terms are removed if p >= 0.10.

Full Information

NCT ID

NCT01937871

First Posted

September 4, 2013

Last Updated

May 25, 2017

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01937871

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostate Hyperplasia, Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

909 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.

Arm Title

5 mg Tadalafil

Arm Type

Experimental

Arm Description

Arm Title

0.2 mg Tamsulosin

Arm Type

Other

Arm Description

Intervention Type

Drug

Intervention Name(s)

5 mg Tadalafil

Other Intervention Name(s)

LY450190

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

0.2 mg Tamsulosin

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 12

Description

Time Frame

Baseline, Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Yes Responses to Question 2 of the Sexual Encounter Profile (SEP) Questionnaire at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IPSS at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Uroflowmetry Measures at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Postvoid Residual Volume (PVR) at Week 12

Description

The amount of urine remaining in the bladder after void completion.

Time Frame

Baseline, Week 12

Title

Change From Baseline in IPSS Storage (Irritative) Subscore at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IPSS Voiding (Obstructive) Subscore at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IPSS Quality of Life (QoL) Index at Week 12

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With Patient Global Impression of Improvement (PGI-I) at Week 12

Description

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).

Time Frame

Week 12

Title

Number of Participants With Clinician Global Impression of Improvement (CGI-I) at Week 12

Description

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).

Time Frame

Week 12

Title

Change From Baseline in IIEF Overall Satisfaction (OS) at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IIEF Intercourse Satisfaction at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IIEF Orgasmic Function at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IIEF Sexual Desire at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in IIEF Subscores at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in Total IPSS at Week 4 and Week 8

Description

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.

Time Frame

Baseline, Week 4; Baseline, Week 8

Title

Change From Baseline in IIEF EF at Week 4 and Week 8

Description

Time Frame

Baseline, Week 4; Baseline, Week 8

Title

Change From Baseline in Yes Responses to Question 2 of the SEP Questionnaire at Week 4 and Week 8

Description

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.

Time Frame

Baseline, Week 4; Baseline, Week 8

Title

Change From Baseline in Yes Responses to Question 3 of the SEP Questionnaire at Week 4 and Week 8

Description

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.

Time Frame

Baseline, Week 4; Baseline, Week 8

Title

Change From Baseline in Modified International Prostate Symptom Score (mIPSS) at Week 2

Description

Time Frame

Baseline, Week 2

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Beijing

ZIP/Postal Code

100020

Country

China

Facility Name

City

Changchun

ZIP/Postal Code

130021

Country

China

Facility Name

City

Changsha

ZIP/Postal Code

410011

Country

China

Facility Name

City

Chengdu

ZIP/Postal Code

610072

Country

China

Facility Name

City

Chongqing

ZIP/Postal Code

400038

Country

China

Facility Name

City

Hangzhou

ZIP/Postal Code

310003

Country

China

Facility Name

City

Hefei

ZIP/Postal Code

230022

Country

China

Facility Name

City

Nanchang

Country

China

Facility Name

City

Nanjing

ZIP/Postal Code

210008

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200040

Country

China

Facility Name

City

Suzhou

ZIP/Postal Code

215006

Country

China

Facility Name

City

Wenzhou

ZIP/Postal Code

325035

Country

China

Facility Name

City

Wu Han

ZIP/Postal Code

430030

Country

China

Facility Name

City

Xi'An

ZIP/Postal Code

710004

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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