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Completed

NCT Number: NCT01037244

Treatment of Erectile Dysfunction I

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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Key information

Age range

19 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Warner Chilcott Investigational Site, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Udenafil

Drug

Tablets via oral administration before an attempt at sexual intercourse.

Placebo

Drug

Tablets via oral administration before an attempt at sexual intercourse.

Primary outcomes

  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)

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  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

    Time frame: Week 12

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 22, 2009
Registry last updated
Dec 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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