Erectile DysfunctionPhase 3NCT01037218
Treatment of Erectile Dysfunction II
A Phase 3 study testing Udenafil in people with Erectile Dysfunction, run by Warner Chilcott at 40 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Udenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 40 sitesUnited States
- Study dates
- Sep 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Warner Chilcott Investigational Site
Arlington, Texas, 76017
Warner Chilcott Investigational Site
Aventura, Florida, 33180
Warner Chilcott Investigational Site
Bay Shore, New York, 11706
Warner Chilcott Investigational Site
Birmingham, Alabama, 35209
Warner Chilcott Investigational Site
Brooklyn, New York, 11219
Warner Chilcott Investigational Site
Cary, North Carolina, 27518
Warner Chilcott Investigational Site
Chino, California, 91710
Warner Chilcott Investigational Site
Cleveland, Ohio, 44122
Warner Chilcott Investigational Site
Dawsonville, Georgia, 30534
Warner Chilcott Investigational Site
Daytona Beach, Florida, 32114
Warner Chilcott Investigational Site
DeLand, Florida, 32720
Warner Chilcott Investigational Site
Elkridge, Maryland, 21075
Warner Chilcott Investigational Site
Englewood, Colorado, 80113
Warner Chilcott Investigational Site
Fort Wayne, Indiana, 46825
Warner Chilcott Investigational Site
Greenbelt, Maryland, 20770
Warner Chilcott Investigational Site
Greenwood, Indiana, 46143
Warner Chilcott Investigational Site
Greer, South Carolina, 29650
Warner Chilcott Investigational Site
Huntsville, Alabama, 35801
Warner Chilcott Investigational Site
Jenkintown, Pennsylvania, 19046
Warner Chilcott Investigational Site
Kingston, New York, 12401
Warner Chilcott Investigational Site
Lancaster, Pennsylvania, 17604-3200
Warner Chilcott Investigational Site
Las Vegas, Nevada, 89106
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, 08648
Warner Chilcott Investigational Site
Milford, Connecticut, 06460
Warner Chilcott Investigational Site
Mountlake Terrace, Washington, 98043
Warner Chilcott Investigational Site
New York, New York, 10016
Warner Chilcott Investigational Site
Norfolk, Virginia, 23502
Warner Chilcott Investigational Site
Ocala, Florida, 34471
Warner Chilcott Investigational Site
Poughkeepsie, New York, 12601
Warner Chilcott Investigational Site
Raleigh, North Carolina, 27609
Warner Chilcott Investigational Site
Raleigh, North Carolina, 27612
Warner Chilcott Investigational Site
Richmond, Virginia, 23294
Warner Chilcott Investigational Site
Salisbury, North Carolina, 28144
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Site
Sandy Springs, Georgia, 30328
Warner Chilcott Investigational Site
Tampa, Florida, 33607
Warner Chilcott Investigational Site
Tarzana, California, 91356
Warner Chilcott Investigational Site
Tempe, Arizona, 85282
Warner Chilcott Investigational Site
West Des Moines, Iowa, 50266
Warner Chilcott Investigational Site
Williamsville, New York, 14221
About this study
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
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).
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Udenafil, Placebo
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UdenafilDrug
Tablets via oral administration before an attempt at sexual intercourse.
PlaceboDrug
Tablets via oral administration before an attempt at sexual intercourse.
| Study group | Role | What they receive |
|---|---|---|
| Udenafil 50 mg | Experimental | 50 mg Udenafil tablet plus 100 \& 150 mg placebo tablets Receives: Drug: Udenafil; Drug: Placebo |
| Udenafil 100 mg | Experimental | 100 mg Udenafil tablet plus 50 \& 150 mg placebo tablets Receives: Drug: Udenafil; Drug: Placebo |
| Udenafil 150mg | Experimental | 150 mg Udenafil tablet plus 50 \& 100 mg placebo tablets Receives: Drug: Udenafil; Drug: Placebo |
| Placebo | Placebo comparator | 50, 100 \& 150 mg placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 - 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?
Measured: Baseline and Week 12
Changes 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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Measured: Baseline and Weeks 1-12
Changes in Sexual Encounter Profile (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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Measured: Baseline and Weeks 1-12
Secondary outcomes (10)
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?
Measured: 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)?
Measured: 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?
Measured: 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?
Measured: Baseline and Week 12
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)
Measured: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT
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?
Measured: Baseline and Week 12
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
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
Measured: Baseline and Week 12
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
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.
Measured: Baseline and Weeks 1-12
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
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.
Measured: Baseline and Weeks 1-12
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
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.
Measured: Baseline and Weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herman Ellman, MD, Study director, Warner Chilcott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037218
- Sponsor's protocol ID
- PR-01309
- Status last verified
- May 2015
- First submitted
- 19 Oct 2009
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01037218
- Acronym / sponsor ID
- PR-01309
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Dec 2009 (estimated)
- Results
- Posted 22 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Udenafil 50 mg | Experimental | Drug: Udenafil, Drug: Placebo50 mg Udenafil tablet plus 100 \& 150 mg placebo tablets |
| Udenafil 100 mg | Experimental | Drug: Udenafil, Drug: Placebo100 mg Udenafil tablet plus 50 \& 150 mg placebo tablets |
| Udenafil 150mg | Experimental | Drug: Udenafil, Drug: Placebo150 mg Udenafil tablet plus 50 \& 100 mg placebo tablets |
| Placebo | Placebo comparator | Drug: Placebo50, 100 \& 150 mg placebo tablets |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UdenafilTablets via oral administration before an attempt at sexual intercourse. | Drug | Udenafil 100 mg, Udenafil 150mg, Udenafil 50 mg |
| PlaceboTablets via oral administration before an attempt at sexual intercourse. | Drug | Placebo, Udenafil 100 mg, Udenafil 150mg, Udenafil 50 mg |
Primary outcome
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 - 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
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. 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
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. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
10 secondary outcomes
Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Time frame: Baseline and Week 12
Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Time frame: Baseline and Week 12
Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Time frame: Baseline and Week 12
Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Time frame: Baseline and Week 12
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
Time frame: Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT
Time frame: Baseline and Week 12
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
Time frame: Baseline and Week 12
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
Time frame: Baseline and Weeks 1-12
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
Time frame: Baseline and Weeks 1-12
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
Time frame: Baseline and Weeks 1-12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herman Ellman, MD study director
Warner Chilcott
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Udenafil in people with Erectile Dysfunction, run by Warner Chilcott at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2015.