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| ID | Type | Description | Link |
|---|---|---|---|
| H6D-US-LVHZ | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil 2.5 mg | Experimental | No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. |
|
| Tadalafil 5 mg | Experimental | No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. |
|
| Placebo | Placebo Comparator | No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | One tablet orally daily |
| |
| Tadalafil |
| Measure | Description | Time Frame |
|---|---|---|
| Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | Cumulative percentage of participants achieving successful intercourse, as measured by "yes" responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse. | 4 days during double-blind period |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 1: "Were you able to achieve at least some erection (some enlargement of the penis)"? Data are presented as the mean percentage of participants who answered "yes". |
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Inclusion Criteria:
Partner Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Indianapolis | Indiana | 46285 |
The first phase of the study was a run-in phase that lasted for approximately 4 weeks. During this time, subjects did not use any form of treatment for erectile dysfunction and were instructed to make at least 4 sexual intercourse attempts with their sexual partner. The purpose of this phase was to obtain baseline data for analysis purposes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tadalafil 2.5 mg | No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. |
| FG001 | Tadalafil 5 mg | No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. |
| FG002 | Placebo | No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 2: Double-blind Treatment Phase |
|
| |||||||||||||||||||||
| Phase 3: Open-label Extension Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tadalafil 2.5 mg | No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. |
| BG001 | Tadalafil 5 mg | No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | Cumulative percentage of participants achieving successful intercourse, as measured by "yes" responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse. | Modified intent-to-treat population consisting of all participants who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Number | cumulative percentage of participants | 4 days during double-blind period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tadalafil 2.5 mg | No drug during baseline period followed by tadalafil 2.5 mg for 14 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
Not provided
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
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| Drug |
Orally once daily |
|
|
| Baseline and 14 days double-blind period |
| Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 2: "Were you able insert your penis into your partner's vagina?" Data are presented as the mean percentage of participants who answered yes. | Baseline and 14 days double-blind period |
| Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of participants who answered "yes". | Baseline and 14 days double-blind period |
| Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 4: "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of participants who answered "yes". | Baseline and 14 days double-blind period |
| Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 5: "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of participants who answered "yes". | Baseline and 14 days double-blind period |
| Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a "yes" response to the sexual encounter profile diary question 3: "Did your erection last long enough for you to have successful intercourse?" Data are based on participants who responded "yes". For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy. | 4 days double-blind period |
| Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the proportion of intercourse attempts for which participants answered "yes" relative to the total number of intercourse attempts. Total number of attempts = TNA. | 14 days during double-blind period |
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | 14 days double-blind and 14 days open-label |
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | 14-day double-blind and 14-day open-label |
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | 14-day double-blind and 14-day open-label |
| Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | 14 days double-blind and 14 days open-label |
| United States |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Sponsor Decision |
|
| Withdrawal by Subject |
|
| NOT COMPLETED |
|
|
| BG002 | Placebo | No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | American Indian or Alaska Native | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Sexual Encounter Profile Diary question number 1 | Sexual Encounter Profile Diary question number 1: "Were you able to achieve at least some erection (some enlargement of the penis)?" Data are presented as the mean percentage of participants who answered yes. | Mean | Standard Deviation | percentage of participants |
|
| Sexual Encounter Profile Diary question number 2 | Sexual Encounter Profile Diary question number 2: "Were you able insert your penis into your partner's vagina?" Data are presented as the mean percentage of participants who answered yes. | Mean | Standard Deviation | percentage of participants |
|
| Sexual Encounter Profile Diary question number 3 | Sexual Encounter Profile Diary question number 3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of participants who answered yes. | Mean | Standard Deviation | percentage of participants |
|
| Sexual Encounter Profile Diary question number 4 | Sexual Encounter Profile Diary question number 4: "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of participants who answered yes. | Mean | Standard Deviation | percentage of participants |
|
| Sexual Encounter Profile Diary question number 5 | Sexual Encounter Profile Diary question number 5: "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of participants who answered yes. | Mean | Standard Deviation | percentage of participants |
|
| OG001 | Tadalafil 5 mg | No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. |
| OG002 | Placebo | No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. |
|
|
|
| Secondary | Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 1: "Were you able to achieve at least some erection (some enlargement of the penis)"? Data are presented as the mean percentage of participants who answered "yes". | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Least Squares Mean | Standard Error | percentage of participants | Baseline and 14 days double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 2: "Were you able insert your penis into your partner's vagina?" Data are presented as the mean percentage of participants who answered yes. | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Least Squares Mean | Standard Error | percentage of participants | Baseline and 14 days double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of participants who answered "yes". | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Least Squares Mean | Standard Error | percentage of participants | Baseline and 14 days double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 4: "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of participants who answered "yes". | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Least Squares Mean | Standard Error | percentage of participants | Baseline and 14 days double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 5: "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of participants who answered "yes". | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Least Squares Mean | Standard Error | percentage of participants | Baseline and 14 days double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a "yes" response to the sexual encounter profile diary question 3: "Did your erection last long enough for you to have successful intercourse?" Data are based on participants who responded "yes". For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy. | Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Median | Standard Error | days | 4 days double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the proportion of intercourse attempts for which participants answered "yes" relative to the total number of intercourse attempts. Total number of attempts = TNA. | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Number | percentage of total number of attempts | 14 days during double-blind period |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Mean | Standard Deviation | percentage successful attempts | 14 days double-blind and 14 days open-label |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization. | Posted | Mean | Standard Deviation | percentage successful attempts | 14-day double-blind and 14-day open-label |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation, who took tadalafil 5 mg during the double-blind treatment period, and who took at least 1 dose of tadalafil 5 mg followed by at least 1 intercourse attempt during the open-label period. | Posted | Mean | Standard Deviation | percentage successful attempts | 14-day double-blind and 14-day open-label |
|
|
|
|
| Secondary | Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period | Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" | Modified intent-to-treat population consisting of all subjects who received tadalafil 2.5 mg in the double-blind study period and did not respond to treatment in that treatment period, who have at least 1 baseline observation and who took at least 1 dose of tadalafil 5 mg in the open-label period followed by at least 1 intercourse attempt. | Posted | Mean | Standard Deviation | percentage successful attempts | 14 days double-blind and 14 days open-label |
|
|
|
|
| 0 |
| 121 |
| 13 |
| 121 |
| EG001 | Tadalafil 5 mg | No drug during baseline period followed by tadalafil 5 mg for 14 days. | 0 | 118 | 12 | 118 |
| EG002 | Placebo | No drug during baseline period followed by placebo for 14 days. | 0 | 133 | 8 | 133 |
| EG003 | Tadalafil 2.5 mg to Tadalafil 5 mg | Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period. | 0 | 111 | 6 | 111 |
| EG004 | Tadalafil 5 mg to Tadalafil 5 mg | Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period. | 0 | 108 | 9 | 108 |
| EG005 | Placebo to Tadalafil 5 mg | Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period. | 0 | 124 | 4 | 124 |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Wound haemorrhage | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Not provided
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Tested was the null-hypothesis that no differences in the percentages of participants who answered "yes" to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg. | ANCOVA | Terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction were included. | <0.001 | No adjustment for multiplicity. | Mean Difference (Final Values) | 12.80 | 2-Sided | 95 | 6.48 | 19.12 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the percentages of participants who answered "yes" to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg. | ANCOVA | Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction. | <0.001 | No adjustment for multiplicity. | Mean Difference (Final Values) | 20.41 | 2-Sided | 95 | 13.50 | 27.31 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the percentages of participants who answered "yes" to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg. | ANCOVA | Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction. | <0.001 | No adjustment for multiplicity. | Mean Difference (Final Values) | 20.54 | 2-Sided | 95 | 13.07 | 28.01 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the percentages of participants who answered "yes" to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg. | ANCOVA | Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction. | <0.001 | No adjustment for multiplicity. | Mean Difference (Final Values) | 21.81 | 2-Sided | 95 | 13.94 | 29.67 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the percentages of participants who answered "yes" to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg. | ANCOVA | Included were terms for baseline value of the efficacy variable, treatment, site, and the baseline-by-treatment interaction. | <0.001 | No adjustment for multiplicity. | Mean Difference (Final Values) | 19.07 | 2-Sided | 95 | 11.40 | 26.75 | No | Superiority or Other |
Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. |
| Log Rank |
| 0.046 |
No adjustment for multiplicity. |
| 95 |
| No |
| Superiority or Other |
|
| <=day12 (TNA: n=827; n=730; n=711) |
|
| <=day11 (TNA: n=774; n=678; n=668) |
|
| <=day10 (TNA: n=726; n=626; n=625) |
|
| <=day9 (TNA: n=668; n=574; n=572) |
|
| <=day8 (TNA: n=608; n=534; n=523) |
|
| <=day7 (TNA: n=563; n=483; n=481) |
|
| <=day6 (TNA: n=505; n=439; n=435) |
|
| <=day5 (TNA: n=464; n=402; n=396) |
|
| <=day4 (TNA: n=412; n=350; n=352) |
|
| <=day3 (TNA: n=324; n=265; n=262) |
|
| <=day2 (TNA: n=214; n=179; n=175) |
|
| <=day1 (TNA: n=109; n=83; n=83) |
|
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=13. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=12. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=11. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=10. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=9. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.002 | P-value for day <=8. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.001 | P-value for day <=7. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.002 | P-value for day <=6. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.002 | P-value for day <=5. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.002 | P-value for day <=4. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.009 | P-value for day <=3. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.038 | P-value for day <=2. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=14. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=13. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=12. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=11. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=10. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=9. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=8. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=7. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=6. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=5. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | <0.001 | P-value for day <=4. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.003 | P-value for day <=3. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.008 | P-value for day <=2. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of "yes" to the sexual encounter profile diary question number 3. | Regression, Logistic | Response = Treatment + Pooled Site + Severity of ED at Baseline. | 0.246 | P-value for day <=1. No adjustment for multiplicity. | 95 | No | Superiority or Other |
| Superiority or Other |
| Superiority or Other |
| Superiority or Other |