Treatment of Erectile Dysfunction I

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01037244
• Collaborator: (none)
• Enrollment: 618
• Locations: 36
• Arms: 4
• Duration (Months): 5.9
• Patients Per Site: 17.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Udenafil; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 618 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Randomized, Placebo-controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
• Study Start Date: Sep 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablets via oral administration before an attempt at sexual intercourse.
Experimental: Udenafil 50 mg	Drug: Udenafil; Tablets via oral administration before an attempt at sexual intercourse.
Experimental: Udenafil 100 mg	Drug: Udenafil; Tablets via oral administration before an attempt at sexual intercourse.
Experimental: Udenafil 150 mg	Drug: Udenafil; Tablets via oral administration before an attempt at sexual intercourse.

Outcome Measures

Primary Outcome Measures

1. 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) [Baseline and Week 12]

   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?

2. Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT [Baseline and Weeks 1 - 12]

   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.

3. Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT [Baseline and Weeks 1 - 12]

   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.

Secondary Outcome Measures

1. 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]

2. Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population [Baseline to Week 12]

   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)

3. Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population [Baseline to Week 12]

   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?

4. Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF [Baseline and Week 12]

   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?

5. Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF [Baseline and Week 12]

   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)?

6. Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF [Baseline and Week 12]

   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?

7. Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF [Baseline and Week 12]

   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?

8. Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT [Baseline and Weeks 1 - 12]

   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.

9. Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT [Baseline and Weeks 1 - 12]

   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.

10. Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT [Baseline and Weeks 1 - 12]

    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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male, at least 19 years of age

• Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity

• History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration

• Partner is not pregnant or lactating

Exclusion Criteria:

• History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months

• Cardiac arrhythmias requiring antiarrhythmic treatment

• Symptomatic congestive heart failure

• Taking nitrate medication in any form

• Uncontrolled diabetes (HbA1c ≥ 13%)

• Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors such as Viagra®, Cialis® or Levitra®

• Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Warner Chilcott Investigational Site	Birmingham	Alabama	United States	35209
2	Warner Chilcott Investigational Site	Homewood	Alabama	United States	35209
3	Warner Chilcott Investigational Site	Mesa	Arizona	United States	85213
4	Warner Chilcott Investigational Site	Phoenix	Arizona	United States	85023
5	Warner Chilcott Investigational Site	Tucson	Arizona	United States	85741
6	Warner Chilcott Investigational Site	Laguna Hills	California	United States	92653
7	Warner Chilcott Investigational Site	Newport Beach	California	United States	92660
8	Warner Chilcott Investigational Site	San Diego	California	United States	92103
9	Warner Chilcott Investigational Site	Torrance	California	United States	90505
10	Warner Chilcott Investigational Site	Denver	Colorado	United States	80211
11	Warner Chilcott Investigational Site	Middlebury	Connecticut	United States	06762
12	Warner Chilcott Investigational Site	New Britain	Connecticut	United States	06052
13	Warner Chilcott Investigational Site	Waterbury	Connecticut	United States	06708
14	Warner Chilcott Investigational Site	Clearwater	Florida	United States	33761
15	Warner Chilcott Investigational Site	Miami	Florida	United States	33143
16	Warner Chilcott Investigational Site	Ocala	Florida	United States	34474
17	Warner Chilcott Investigational Site	Columbus	Georgia	United States	31904
18	Warner Chilcott Investigational Site	Melrose Park	Illinois	United States	60160
19	Warner Chilcott Investigational Site	Jeffersonville	Indiana	United States	47130
20	Warner Chilcott Investigational Site	Omaha	Nebraska	United States	68114
21	Warner Chilcott Investigational Site	Garden City	New York	United States	11530
22	Warner Chilcott Investigational Site	New York	New York	United States	10016
23	Warner Chilcott Investigational Site	Rochester	New York	United States	14609
24	Warner Chilcott Investigational Site	Chapel Hill	North Carolina	United States	27514
25	Warner Chilcott Investigational Site	Charlotte	North Carolina	United States	28226
26	Warner Chilcott Investigational Site	Concord	North Carolina	United States	28025
27	Warner Chilcott Investigational Site	Wilmington	North Carolina	United States	28401
28	Warner Chilcott Investigational Site	Winston-Salem	North Carolina	United States	27103
29	Warner Chilcott Investigational Site	Cincinnati	Ohio	United States	45212
30	Warner Chilcott Investigational Site	Bala Cynwyd	Pennsylvania	United States	19004
31	Warner Chilcott Investigational Site	Mt. Pleasant	South Carolina	United States	29464
32	Warner Chilcott Investigational Site	Myrtle Beach	South Carolina	United States	29572
33	Warner Chilcott Investigational Site	Sugar Land	Texas	United States	77479
34	Warner Chilcott Investigational Site	Salt Lake City	Utah	United States	84107
35	Warner Chilcott Investigational Site	Spokane	Washington	United States	99204
36	Warner Chilcott Investigational Site	Spokane	Washington	United States	99208

Sponsors and Collaborators

• Warner Chilcott

Investigators

• Study Director: Herman Ellman, MD, Warner Chilcott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT01037244
• Other Study ID Numbers: PR-01209
• First Posted: Dec 22, 2009
• Last Update Posted: Dec 22, 2011
• Last Verified: Dec 1, 2011

• Additional relevant MeSH terms: Erectile Dysfunction; Udenafil

Study Results

Participant Flow

Recruitment Details	Enrollment began 28 Sep 2009

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Period Title: Overall Study
STARTED	154	152	158	154
mITT (Modified Intent-to-Treat)	150	148	154	153
Safety Population	155	150	159	152
COMPLETED	141	138	144	140
NOT COMPLETED	13	14	14	14

Baseline Characteristics

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo	Total
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets	Total of all reporting groups
Overall Participants	154	152	158	154	618
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.0 (10.03)	59.5 (9.69)	58.5 (10.75)	60.3 (10.16)	59.3 (10.17)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	154 100%	152 100%	158 100%	154 100%	618 100%
Region of Enrollment (participants) [Number]
United States	154 100%	152 100%	158 100%	154 100%	618 100%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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?
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	4.85 (7.78)	6.98 (7.82)	7.76 (8.53)	-0.19 (5.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Baseline Domain Score and pooled sites as covariates.
Method of Estimation	Estimation Parameter	Difference in Least Square (LS) Means
	Estimated Value	5.04
	Confidence Interval	(2-Sided) 95%; 3.36 to 6.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Baseline domain score and pooled sites as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	7.18
	Confidence Interval	(2-Sided) 95%; 5.49 to 8.86
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	Baseline domain score and pooled sites as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	7.95
	Confidence Interval	(2-Sided) 95%; 6.27 to 9.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
Description	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.
Time Frame	Baseline and Weeks 1 - 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [Percentage Yes Responders]	16.74	27.16	29.65	-1.86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	18.60
	Confidence Interval	(2-Sided) 95%; 11.72 to 25.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	29.02
	Confidence Interval	(2-Sided) 95%; 22.13 to 35.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	31.51
	Confidence Interval	(2-Sided) 95%; 24.68 to 38.34
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

mITT Population

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Number [participants]	82 53.2%	92 60.5%	111 70.3%	26 16.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Udenafil 100 mg, Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Cochran-Armitage test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
Description	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)
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

mITT Population

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.38	0.62	0.75	-0.06

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95%; 0.54 to 0.83
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	p-values are obtained from ANCOVA model with baseline PSAE score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.80
	Confidence Interval	(2-Sided) 95%; 0.66 to 0.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
Description	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?
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

mITT Population

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	59.59	65.49	71.31	42.92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	p-values are obtained from ANOVA model with pooled site as a covariate.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	16.67
	Confidence Interval	(2-Sided) 95%; 11.23 to 22.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	p-values are obtained from ANOVA model with pooled site as a covariate.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	22.57
	Confidence Interval	(2-Sided) 95%; 17.11 to 28.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANOVA
	Comments	p-values are obtained from ANOVA model with pooled site as a covariate.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	28.39
	Confidence Interval	(2-Sided) 95%; 22.98 to 33.79
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description	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?
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	1.81	2.18	2.93	-0.09

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values were obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	1.89
	Confidence Interval	(2-Sided) 95%; 1.17 to 2.61
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	2.27
	Confidence Interval	(2-Sided) 95%; 1.54 to 2.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	3.02
	Confidence Interval	(2-Sided) 95%; 2.30 to 3.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description	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)?
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	1.37	1.60	1.93	-0.05

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	1.42
	Confidence Interval	(2-Sided) 95%; 0.81 to 2.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	1.65
	Confidence Interval	(2-Sided) 95%; 1.04 to 2.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	1.98
	Confidence Interval	(2-Sided) 95%; 1.37 to 2.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description	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?
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.45	0.61	0.73	-0.12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0019
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 95%; 0.21 to 0.93
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.74
	Confidence Interval	(2-Sided) 95%; 0.38 to 1.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95%; 0.49 to 1.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description	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?
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Last Observation Carried Forward (LOCF), Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [units on a scale]	1.98	2.08	2.88	0.32

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	1.66
	Confidence Interval	(2-Sided) 95%; 1.13 to 2.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	1.76
	Confidence Interval	(2-Sided) 95%; 1.23 to 2.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with Baseline domain score and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	2.56
	Confidence Interval	(2-Sided) 95%; 2.03 to 3.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
Description	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.
Time Frame	Baseline and Weeks 1 - 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [Percentage of Yes Responders]	0.60	7.55	7.42	-11.74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	12.34
	Confidence Interval	(2-Sided) 95%; 7.29 to 17.40
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	19.29
	Confidence Interval	(2-Sided) 95%; 14.23 to 24.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled sites as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	19.16
	Confidence Interval	(2-Sided) 95%; 14.14 to 24.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
Description	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.
Time Frame	Baseline and Weeks 1 - 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [Percentage of Yes Responders]	27.36	32.83	45.55	9.30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	18.07
	Confidence Interval	(2-Sided) 95%; 10.70 to 25.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	23.53
	Confidence Interval	(2-Sided) 95%; 16.12 to 30.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	36.25
	Confidence Interval	(2-Sided) 95%; 28.92 to 43.59
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
Description	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.
Time Frame	Baseline and Weeks 1 - 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [Percentage of Yes Responders]	26.72	33.78	45.52	8.53

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	18.20
	Confidence Interval	(2-Sided) 95%; 10.79 to 25.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	25.25
	Confidence Interval	(2-Sided) 95%; 17.82 to 32.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	36.99
	Confidence Interval	(2-Sided) 95%; 29.63 to 44.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Primary Outcome

Title	Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
Description	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.
Time Frame	Baseline and Weeks 1 - 12

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat (mITT)

Arm/Group Title	Udenafil 50 mg	Udenafil 100 mg	Udenafil 150mg	Placebo
Arm/Group Description	Udenafil 50 mg tablets	Udenafil 100 mg tablets	Udenafil 150mg tablets	Placebo tablets
Measure Participants	150	148	154	153
Least Squares Mean (95% Confidence Interval) [Percentage Yes Responders]	31.17	38.78	49.00	11.20

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Udenafil 50 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	19.98
	Confidence Interval	(2-Sided) 95%; 12.69 to 27.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Udenafil 100 mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	27.58
	Confidence Interval	(2-Sided) 95%; 20.29 to 34.88
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Udenafil 150mg, Placebo
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	ANCOVA
	Comments	P-values are obtained from ANCOVA model with proportion of "yes" responses during the baseline period and pooled site as covariates.
Method of Estimation	Estimation Parameter	Difference in LS Means
	Estimated Value	37.80
	Confidence Interval	(2-Sided) 95%; 30.57 to 45.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	12-week treatment period
Arm/Group Title	Udenafil 50 mg		Udenafil 100 mg		Udenafil 150mg		Placebo
Arm/Group Description	Udenafil 50 mg tablets		Udenafil 100 mg tablets		Udenafil 150mg tablets		Placebo tablets
All Cause Mortality
	Udenafil 50 mg		Udenafil 100 mg		Udenafil 150mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Udenafil 50 mg		Udenafil 100 mg		Udenafil 150mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/155 (1.3%)		4/150 (2.7%)		1/159 (0.6%)		2/152 (1.3%)
Cardiac disorders
Iscemic Cardiomyopathy	1/155 (0.6%)	1	0/150 (0%)	0	0/159 (0%)	0	0/152 (0%)	0
Endocrine disorders
Goiter	0/155 (0%)	0	0/150 (0%)	0	1/159 (0.6%)	1	0/152 (0%)	0
Eye disorders
Unilateral Blindness	0/155 (0%)	0	0/150 (0%)	0	0/159 (0%)	0	1/152 (0.7%)	1
Retinal Artery Embolism	0/155 (0%)	0	0/150 (0%)	0	0/159 (0%)	0	1/152 (0.7%)	1
Gastrointestinal disorders
Gastroesophageal Reflux Disease	0/155 (0%)	0	1/150 (0.7%)	1	0/159 (0%)	0	0/152 (0%)	0
Infections and infestations
Pharyngeal Abscess	0/155 (0%)	0	0/150 (0%)	0	0/159 (0%)	0	1/152 (0.7%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue Neoplasm Malignant Stage Unspecified	1/155 (0.6%)	1	0/150 (0%)	0	0/159 (0%)	0	0/152 (0%)	0
Lung Neoplasm	0/155 (0%)	0	1/150 (0.7%)	1	0/159 (0%)	0	0/152 (0%)	0
Nervous system disorders
Carotid Artery Disease	0/155 (0%)	0	0/150 (0%)	0	0/159 (0%)	0	1/152 (0.7%)	1
Transient Ischemic Attack	0/155 (0%)	0	0/150 (0%)	0	0/159 (0%)	0	1/152 (0.7%)	1
Brain Stem Infarction	0/155 (0%)	0	1/150 (0.7%)	1	0/159 (0%)	0	0/152 (0%)	0
Hemorrhagic Cerebral Infarction	0/155 (0%)	0	1/150 (0.7%)	1	0/159 (0%)	0	0/152 (0%)	0
Skin and subcutaneous tissue disorders
Hypoesthesia Facial	0/155 (0%)	0	1/150 (0.7%)	1	0/159 (0%)	0	0/152 (0%)	0
Vascular disorders
Deep Vein Thrombosis	0/155 (0%)	0	1/150 (0.7%)	1	0/159 (0%)	0	0/152 (0%)	0
Other (Not Including Serious) Adverse Events
	Udenafil 50 mg		Udenafil 100 mg		Udenafil 150mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	43/155 (27.7%)		57/150 (38%)		70/159 (44%)		35/152 (23%)
Gastrointestinal disorders
Dyspepsia	3/155 (1.9%)		4/150 (2.7%)		4/159 (2.5%)		1/152 (0.7%)
Nausea	3/155 (1.9%)		5/150 (3.3%)		2/159 (1.3%)		2/152 (1.3%)
Infections and infestations
Nasopharyngitis	5/155 (3.2%)		11/150 (7.3%)		7/159 (4.4%)		8/152 (5.3%)
Upper Respiratory Tract Infection	7/155 (4.5%)		6/150 (4%)		6/159 (3.8%)		4/152 (2.6%)
Sinusitis	3/155 (1.9%)		3/150 (2%)		4/159 (2.5%)		4/152 (2.6%)
Influenza	3/155 (1.9%)		3/150 (2%)		2/159 (1.3%)		2/152 (1.3%)
Investigations
Blood Creatine Phosphokinase Increased	4/155 (2.6%)		2/150 (1.3%)		2/159 (1.3%)		4/152 (2.6%)
Musculoskeletal and connective tissue disorders
Back Pain	3/155 (1.9%)		4/150 (2.7%)		1/159 (0.6%)		1/152 (0.7%)
Nervous system disorders
Headache	2/155 (1.3%)		8/150 (5.3%)		19/159 (11.9%)		4/152 (2.6%)
Respiratory, thoracic and mediastinal disorders
Nasal Congestion	2/155 (1.3%)		3/150 (2%)		11/159 (6.9%)		0/152 (0%)
Sinus Congestion	2/155 (1.3%)		3/150 (2%)		2/159 (1.3%)		4/152 (2.6%)
Vascular disorders
Flushing	6/155 (3.9%)		5/150 (3.3%)		10/159 (6.3%)		1/152 (0.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.