Erectile Dysfunction
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.
Interventions
DRUGTadalafil
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
22 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Have a history of erectile dysfunction for at least 3 months. * Are sexually active and willing to remain sexually active with the same female partner during the study. * Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day. * Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.
Exclusion criteria
* Have erectile dysfunction, which is caused by any other primary sexual disorder. * Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants). * Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant. * Have human immunodeficiency virus (HIV) infection. * Are using certain kinds of medicines, which are not allowed in this study. * Are allergic to tadalafil. * Are planning to father a baby or are in a relationship with a pregnant partner. * Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial. * Have participated or discontinued from any other tadalafil clinical trial. * Have a history of drug, alcohol, or substance abuse within the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | Baseline through Month 12 | A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
| Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | Baseline through Month 12 | Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Month 1, Month 3 | Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period. |
| Percentage of Participants Achieving Normal Erectile Functioning | Month 1, Month 3 | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 1 and Month 3. |
| Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Baseline, Month 1; Baseline, Month 3 | IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline\*visit, where participant is a random effect. |
| Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3, Month12, Month 24 | Participants with yes responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity? |
| Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 6, Month 12, Month 18, Month 24 | Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 6 and Month 12. |
| Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24 | IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline\*visit, where participant is a random effect. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2.5 mg/5 mg Tadalafil 2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2). | 211 |
| 5 mg Tadalafil 5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2). | 424 |
| Total | 635 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (Month 3) | Adverse Event | 2 | 1 |
| Period 1 (Month 3) | Lost to Follow-up | 3 | 8 |
| Period 1 (Month 3) | Protocol Violation | 4 | 8 |
| Period 1 (Month 3) | Sponsor Decision | 2 | 1 |
| Period 1 (Month 3) | Withdrawal by Subject | 8 | 18 |
| Period 2 (Month 12 to Month 24) | Adverse Event | 3 | 4 |
| Period 2 (Month 12 to Month 24) | Death | 1 | 0 |
| Period 2 (Month 12 to Month 24) | Lost to Follow-up | 7 | 13 |
| Period 2 (Month 12 to Month 24) | Physician Decision | 0 | 2 |
| Period 2 (Month 12 to Month 24) | Protocol Violation | 4 | 11 |
| Period 2 (Month 12 to Month 24) | Sponsor Decision | 2 | 1 |
| Period 2 (Month 12 to Month 24) | Withdrawal by Subject | 25 | 43 |
| Period 2 (Month 3 to Month 12) | Adverse Event | 1 | 2 |
| Period 2 (Month 3 to Month 12) | Lost to Follow-up | 3 | 5 |
| Period 2 (Month 3 to Month 12) | Physician Decision | 0 | 2 |
| Period 2 (Month 3 to Month 12) | Protocol Violation | 0 | 3 |
| Period 2 (Month 3 to Month 12) | Withdrawal by Subject | 15 | 19 |
Baseline characteristics
| Characteristic | 2.5 mg/5 mg Tadalafil | Total | 5 mg Tadalafil |
|---|---|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 11.11 | 43.6 years STANDARD_DEVIATION 10.98 | 44.1 years STANDARD_DEVIATION 10.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 211 Participants | 635 Participants | 424 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 211 Participants | 635 Participants | 424 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 211 Participants | 635 Participants | 424 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 86 / 210 | 178 / 421 |
| serious Total, serious adverse events | 15 / 210 | 17 / 421 |
Outcome results
Primary
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline through Month 12
Population: All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | 1.4 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation | 0.7 percentage of participants |
Primary
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Time frame: Baseline through Month 12
Population: All enrolled participants who fulfill the study entry criteria and who receive at least one dose of tadalafil.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | 33.8 Percentage of participants |
| 5 mg Tadalafil | Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious) | 35.9 Percentage of participants |
Secondary
Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline\*visit, where participant is a random effect.
Time frame: Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24
Population: All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 2.5 mg/5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 18 | 8.6 units on a scale | Standard Error 0.39 |
| 2.5 mg/5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 12 | 8.1 units on a scale | Standard Error 0.43 |
| 2.5 mg/5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 24 | 8.6 units on a scale | Standard Error 0.44 |
| 2.5 mg/5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 6 | 8.2 units on a scale | Standard Error 0.38 |
| 5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 6 | 7.9 units on a scale | Standard Error 0.27 |
| 5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 24 | 8.5 units on a scale | Standard Error 0.28 |
| 5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 12 | 7.9 units on a scale | Standard Error 0.27 |
| 5 mg Tadalafil | Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments | Month 18 | 8.3 units on a scale | Standard Error 0.27 |
Secondary
Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score
IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (no sexual activity for Question 1, no sexual stimulation for Question 2 and did not attempt intercourse for Questions 3-5) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Least Squares (LS) mean of the change from baseline is from Mixed effect Model Repeat Measurement (MMRM) model. The model included covariates baseline + visit + pooled investigator + baseline\*visit, where participant is a random effect.
Time frame: Baseline, Month 1; Baseline, Month 3
Population: All enrolled participants who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| 2.5 mg/5 mg Tadalafil | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Month 1 | 4.5 units on a scale | Standard Error 0.42 |
| 2.5 mg/5 mg Tadalafil | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Month 3 | 6.1 units on a scale | Standard Error 0.44 |
| 5 mg Tadalafil | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Month 1 | 6.2 units on a scale | Standard Error 0.28 |
| 5 mg Tadalafil | Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score | Month 3 | 7.4 units on a scale | Standard Error 0.28 |
Secondary
Percentage of Participants Achieving Normal Erectile Functioning
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 1 and Month 3.
Time frame: Month 1, Month 3
Population: All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning | Month 1 | 22.2 Percentage of partcipants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning | Month 3 | 31.6 Percentage of partcipants |
| 5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning | Month 1 | 30.9 Percentage of partcipants |
| 5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning | Month 3 | 37.6 Percentage of partcipants |
Secondary
Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments
Participants achieving a normal erectile functioning (defined as having an IIEF-EF Domain score of \>=26) at Month 6 and Month 12.
Time frame: Month 6, Month 12, Month 18, Month 24
Population: All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 6 | 38.2 Percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 12 | 44.1 Percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 18 | 44.6 Percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 24 | 45.5 Percentage of participants |
| 5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 24 | 48.2 Percentage of participants |
| 5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 6 | 42.3 Percentage of participants |
| 5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 18 | 43.7 Percentage of participants |
| 5 mg Tadalafil | Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments | Month 12 | 43.5 Percentage of participants |
Secondary
Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2
Participants with yes responses to GAQ Question 1 (GAQ1) and GAQ Question 2 (GAQ2) of the GAQ questionnaire at Month 3 and Month 12. GAQ1: Has the treatment you have been taking during this study improved your erections? GAQ2: If yes, has the treatment improved your ability to engage in sexual activity?
Time frame: Month 3, Month12, Month 24
Population: All randomized participants who had evaluable data for Global Assessment Questions (GAQ)1 and GAQ2.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 24: GAQ2 | 96.2 percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 12: GAQ1 | 96.6 percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 12: GAQ2 | 95.5 percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 24: GAQ1 | 96.8 percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3: GAQ1 | 89.6 percentage of participants |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3: GAQ2 | 86.5 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3: GAQ1 | 95.7 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 12: GAQ2 | 96.1 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 24: GAQ2 | 94.5 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 3: GAQ2 | 92.1 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 12: GAQ1 | 97.5 percentage of participants |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Global Assessment Questions (GAQ)1 and GAQ2 | Month 24: GAQ1 | 95.7 percentage of participants |
Secondary
Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary
Participant-assessed diary has 5 questions(QI-Q5): 4 of the 5 questions were analyzed. Q2: successful penetration, Q3: successful intercourse, Q4: satisfied with erection, and Q5: satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1-Q5 scores were determined as the percentage of 'Yes' responses to each of the 5 questions out of all sexual attempts recorded during the time period.
Time frame: Month 1, Month 3
Population: All enrolled subjects who fulfill the study entry criteria, receive at least one dose of tadalafil, and have both baseline and postbaseline data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q2: successful penetration,Month 1 | 81.3 Percentage of participants | Standard Deviation 34.58 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q3: successful intercourse,Month 1 | 41.2 Percentage of participants | Standard Deviation 41.48 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q3: successful intercourse,Month 3 | 55.7 Percentage of participants | Standard Deviation 43.19 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q4: satisfied with erection, Month 3 | 39.9 Percentage of participants | Standard Deviation 43.73 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q5: satisfied with sexual experience,Month 3 | 35.7 Percentage of participants | Standard Deviation 41.93 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q2: successful penetration,Month 3 | 88.2 Percentage of participants | Standard Deviation 28.55 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q4: satisfied with erection, Month 1 | 24.8 Percentage of participants | Standard Deviation 35.62 |
| 2.5 mg/5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q5: satisfied with sexual experience,Month 1 | 20.4 Percentage of participants | Standard Deviation 32.81 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q2: successful penetration,Month 1 | 86.7 Percentage of participants | Standard Deviation 27.58 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q4: satisfied with erection, Month 3 | 43.5 Percentage of participants | Standard Deviation 43.46 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q2: successful penetration,Month 3 | 91.7 Percentage of participants | Standard Deviation 23.11 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q4: satisfied with erection, Month 1 | 35.5 Percentage of participants | Standard Deviation 41.63 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q3: successful intercourse,Month 1 | 49.5 Percentage of participants | Standard Deviation 42.85 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q5: satisfied with sexual experience,Month 1 | 31.1 Percentage of participants | Standard Deviation 40.5 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q3: successful intercourse,Month 3 | 60.1 Percentage of participants | Standard Deviation 42.39 |
| 5 mg Tadalafil | Percentage of Participants With Yes Responses to Sexual Encounter Profile (SEP) Diary | Q5: satisfied with sexual experience,Month 3 | 39.2 Percentage of participants | Standard Deviation 43.06 |