Treatment of Erectile Dysfunction II

Phase 3

Completed

Conditions: Erectile Dysfunction

Interventions: Drug: Udenafil
Drug: Placebo

Registration Number: NCT01037218

Lead Sponsor: Warner Chilcott

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).

Detailed Description: Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 601

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®

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Udenafil 50 mg	Placebo	50 mg Udenafil tablet plus 100 \& 150 mg placebo tablets
Udenafil 100 mg	Placebo	100 mg Udenafil tablet plus 50 \& 150 mg placebo tablets
Placebo	Placebo	50, 100 \& 150 mg placebo tablets
Udenafil 150mg	Placebo	150 mg Udenafil tablet plus 50 \& 100 mg placebo tablets
Udenafil 50 mg	Udenafil	50 mg Udenafil tablet plus 100 \& 150 mg placebo tablets
Udenafil 100 mg	Udenafil	100 mg Udenafil tablet plus 50 \& 150 mg placebo tablets
Udenafil 150mg	Udenafil	150 mg Udenafil tablet plus 50 \& 100 mg placebo tablets

Primary Outcome Measures

Name	Time	Method
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 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? 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?
Changes 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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Changes in Sexual Encounter Profile (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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.

Secondary Outcome Measures

Name	Time	Method
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population	Week 12	While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT	Baseline and Week 12	EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you 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 has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?
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?
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)?
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population	Baseline and Week 12	PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT	Baseline and Weeks 1-12	SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
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?
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?
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT	Baseline and Weeks 1-12	SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT	Baseline and Weeks 1-12	SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.