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Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Udenafil 50 mg | Experimental |
| |
| Udenafil 100 mg | Experimental |
| |
| Udenafil 150 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Udenafil | Drug | Tablets via oral administration before an attempt at sexual intercourse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection? | Baseline and Week 12 |
| Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Baseline and Weeks 1 - 12 |
| Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Baseline and Weeks 1 - 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population | Week 12 | |
| Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Ellman, MD | Warner Chilcott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warner Chilcott Investigational Site | Birmingham | Alabama | 35209 | United States | ||
| Warner Chilcott Investigational Site |
Not provided
Enrollment began 28 Sep 2009
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Udenafil 50 mg | Udenafil 50 mg tablets |
| FG001 | Udenafil 100 mg | Udenafil 100 mg tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Tablets via oral administration before an attempt at sexual intercourse. |
|
PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)
| Baseline to Week 12 |
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population | EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness? | Baseline to Week 12 |
| Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse? | Baseline and Week 12 |
| Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Orgasmic Function domain: 0 (poor) - 5/(good) scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)? | Baseline and Week 12 |
| Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Sexual Desire domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire? | Baseline and Week 12 |
| Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Overall Satisfaction domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner? | Baseline and Week 12 |
| Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT | Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Baseline and Weeks 1 - 12 |
| Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Baseline and Weeks 1 - 12 |
| Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT | Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Baseline and Weeks 1 - 12 |
| Homewood |
| Alabama |
| 35209 |
| United States |
| Warner Chilcott Investigational Site | Mesa | Arizona | 85213 | United States |
| Warner Chilcott Investigational Site | Phoenix | Arizona | 85023 | United States |
| Warner Chilcott Investigational Site | Tucson | Arizona | 85741 | United States |
| Warner Chilcott Investigational Site | Laguna Hills | California | 92653 | United States |
| Warner Chilcott Investigational Site | Newport Beach | California | 92660 | United States |
| Warner Chilcott Investigational Site | San Diego | California | 92103 | United States |
| Warner Chilcott Investigational Site | Torrance | California | 90505 | United States |
| Warner Chilcott Investigational Site | Denver | Colorado | 80211 | United States |
| Warner Chilcott Investigational Site | Middlebury | Connecticut | 06762 | United States |
| Warner Chilcott Investigational Site | New Britain | Connecticut | 06052 | United States |
| Warner Chilcott Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Warner Chilcott Investigational Site | Clearwater | Florida | 33761 | United States |
| Warner Chilcott Investigational Site | Miami | Florida | 33143 | United States |
| Warner Chilcott Investigational Site | Ocala | Florida | 34474 | United States |
| Warner Chilcott Investigational Site | Columbus | Georgia | 31904 | United States |
| Warner Chilcott Investigational Site | Melrose Park | Illinois | 60160 | United States |
| Warner Chilcott Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| Warner Chilcott Investigational Site | Omaha | Nebraska | 68114 | United States |
| Warner Chilcott Investigational Site | Garden City | New York | 11530 | United States |
| Warner Chilcott Investigational Site | New York | New York | 10016 | United States |
| Warner Chilcott Investigational Site | Rochester | New York | 14609 | United States |
| Warner Chilcott Investigational Site | Chapel Hill | North Carolina | 27514 | United States |
| Warner Chilcott Investigational Site | Charlotte | North Carolina | 28226 | United States |
| Warner Chilcott Investigational Site | Concord | North Carolina | 28025 | United States |
| Warner Chilcott Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Warner Chilcott Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| Warner Chilcott Investigational Site | Cincinnati | Ohio | 45212 | United States |
| Warner Chilcott Investigational Site | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Warner Chilcott Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Warner Chilcott Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Warner Chilcott Investigational Site | Sugar Land | Texas | 77479 | United States |
| Warner Chilcott Investigational Site | Salt Lake City | Utah | 84107 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99204 | United States |
| Warner Chilcott Investigational Site | Spokane | Washington | 99208 | United States |
| FG002 |
| Udenafil 150mg |
Udenafil 150mg tablets |
| FG003 | Placebo | Placebo tablets |
| mITT (Modified Intent-to-Treat) |
|
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Udenafil 50 mg | Udenafil 50 mg tablets |
| BG001 | Udenafil 100 mg | Udenafil 100 mg tablets |
| BG002 | Udenafil 150mg | Udenafil 150mg tablets |
| BG003 | Placebo | Placebo tablets |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Safety Population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) | Erectile Function domain: 0 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection? | Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Yes Responders | Baseline and Weeks 1 - 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population | mITT Population | Posted | Number | participants | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population | PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max) | mITT Population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population | EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness? | mITT Population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse? | Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Orgasmic Function domain: 0 (poor) - 5/(good) scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)? | Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Sexual Desire domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire? | Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF | Overall Satisfaction domain: 1 (poor) - 5/(good) scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner? | Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline and Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT | Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Yes Responders | Baseline and Weeks 1 - 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Yes Responders | Baseline and Weeks 1 - 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT | Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of Yes Responders | Baseline and Weeks 1 - 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT | Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period. | Modified Intent-to-Treat (mITT) | Posted | Least Squares Mean | 95% Confidence Interval | Percentage Yes Responders | Baseline and Weeks 1 - 12 |
|
|
12-week treatment period
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Udenafil 50 mg | Udenafil 50 mg tablets | 2 | 155 | 43 | 155 | ||
| EG001 | Udenafil 100 mg | Udenafil 100 mg tablets | 4 | 150 | 57 | 150 | ||
| EG002 | Udenafil 150mg | Udenafil 150mg tablets | 1 | 159 | 70 | 159 | ||
| EG003 | Placebo | Placebo tablets | 2 | 152 | 35 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Carotid Artery Disease | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Unilateral Blindness | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Retinal Artery Embolism | Eye disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Transient Ischemic Attack | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Pharyngeal Abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Tongue Neoplasm Malignant Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Iscemic Cardiomyopathy | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Brain Stem Infarction | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypoesthesia Facial | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Gastroesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hemorrhagic Cerebral Infarction | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lung Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Goiter | Endocrine disorders | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Blood Creatine Phosphokinase Increased | Investigations | MedDRA (12.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C419664 | udenafil |
Not provided
Not provided
Not provided
| Male |
|
| 540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. | ANCOVA | Baseline domain score and pooled sites as covariates. | <0.0001 | Difference in LS Means | 7.18 | 2-Sided | 95 | 5.49 | 8.86 | No | Superiority or Other |
| 540 subjects were randomized with 1:1:1:1 randomization scheme to achieve approximately 135 eligible subjects randomized to each of the 4 treatment groups (WC3043 50 mg, 100 mg, 150 mg, and placebo). 135 subjects for each group vs. Placebo will provide at least 90% power with effect size from 0.41-0.44, 0.74-0.90 and 0.46-0.95 on 50 mg, 100 mg and 150 mg groups, respectively. Adjusted power is at least 90% using Bonferroni adjustment on hierarchical testing procedure. | ANCOVA | Baseline domain score and pooled sites as covariates. | <0.0001 | Difference in LS Means | 7.95 | 2-Sided | 95 | 6.27 | 9.63 | No | Superiority or Other |
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