Erectile DysfunctionPhase 3NCT01037244

Treatment of Erectile Dysfunction I

A Phase 3 study testing Udenafil in people with Erectile Dysfunction, run by Warner Chilcott at 36 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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: 618 participants
Where: 36 sitesUnited States
Study dates: Sep 2009to Mar 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

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Warner Chilcott Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Warner Chilcott Investigational Site
Birmingham, Alabama, 35209
Warner Chilcott Investigational Site
Chapel Hill, North Carolina, 27514
Warner Chilcott Investigational Site
Charlotte, North Carolina, 28226
Warner Chilcott Investigational Site
Cincinnati, Ohio, 45212
Warner Chilcott Investigational Site
Clearwater, Florida, 33761
Warner Chilcott Investigational Site
Columbus, Georgia, 31904
Warner Chilcott Investigational Site
Concord, North Carolina, 28025
Warner Chilcott Investigational Site
Denver, Colorado, 80211
Warner Chilcott Investigational Site
Garden City, New York, 11530
Warner Chilcott Investigational Site
Homewood, Alabama, 35209
Warner Chilcott Investigational Site
Jeffersonville, Indiana, 47130
Warner Chilcott Investigational Site
Laguna Hills, California, 92653
Warner Chilcott Investigational Site
Melrose Park, Illinois, 60160
Warner Chilcott Investigational Site
Mesa, Arizona, 85213
Warner Chilcott Investigational Site
Miami, Florida, 33143
Warner Chilcott Investigational Site
Middlebury, Connecticut, 06762
Warner Chilcott Investigational Site
Mt. Pleasant, South Carolina, 29464
Warner Chilcott Investigational Site
Myrtle Beach, South Carolina, 29572
Warner Chilcott Investigational Site
New Britain, Connecticut, 06052
Warner Chilcott Investigational Site
New York, New York, 10016
Warner Chilcott Investigational Site
Newport Beach, California, 92660
Warner Chilcott Investigational Site
Ocala, Florida, 34474
Warner Chilcott Investigational Site
Omaha, Nebraska, 68114
Warner Chilcott Investigational Site
Phoenix, Arizona, 85023
Warner Chilcott Investigational Site
Rochester, New York, 14609
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84107
Warner Chilcott Investigational Site
San Diego, California, 92103
Warner Chilcott Investigational Site
Spokane, Washington, 99204
Warner Chilcott Investigational Site
Spokane, Washington, 99208
Warner Chilcott Investigational Site
Sugar Land, Texas, 77479
Warner Chilcott Investigational Site
Torrance, California, 90505
Warner Chilcott Investigational Site
Tucson, Arizona, 85741
Warner Chilcott Investigational Site
Waterbury, Connecticut, 06708
Warner Chilcott Investigational Site
Wilmington, North Carolina, 28401
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103

Other trials in United States

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

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 groups in NCT01037244
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Udenafil 50 mg	Experimental	Not described Receives: Drug: Udenafil
Udenafil 100 mg	Experimental	Not described Receives: Drug: Udenafil
Udenafil 150 mg	Experimental	Not described Receives: Drug: Udenafil

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 (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?
Measured: Baseline and Week 12
Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Measured: Baseline and Weeks 1 - 12
Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Measured: Baseline and Weeks 1 - 12

Secondary outcomes (10)

Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
Measured: Week 12
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)
Measured: Baseline to Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use? How satisfied w/how quickly it works? How long it lasts? How confident made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?
Measured: Baseline to Week 12
Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?
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
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Measured: Baseline and Weeks 1 - 12
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Measured: Baseline and Weeks 1 - 12
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
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.

Sep 2009Mar 2010

First posted22 Dec 2009 (estimated)
Study startSep 2009
Primary completionMar 2010
Study completionMar 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: 618 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01037244
Sponsor's protocol ID: PR-01209
Status last verified: Dec 2011
First submitted: 19 Oct 2009
Last updated: 22 Dec 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation

All Erectile Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2011. 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: NCT01037244
Acronym / sponsor ID: PR-01209
Conditions: Erectile Dysfunction
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 618 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Mar 2010 (actual)
Study completion: Mar 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.

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
Placebo	Placebo comparator	Drug: Placebo
Udenafil 50 mg	Experimental	Drug: Udenafil
Udenafil 100 mg	Experimental	Drug: Udenafil
Udenafil 150 mg	Experimental	Drug: Udenafil

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 150 mg, Udenafil 50 mg
PlaceboTablets via oral administration before an attempt at sexual intercourse.	Drug	Placebo

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 (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?
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.
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.

10 secondary outcomes

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
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
Time frame: Baseline to Week 12
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
Time frame: Baseline to Week 12
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
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

Results posted to the registry on 22 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Udenafil 50 mg	154	141
Udenafil 100 mg	152	138
Udenafil 150mg	158	144
Placebo	154	140

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. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Udenafil 50 mg n = 150	Udenafil 100 mg n = 148	Udenafil 150mg n = 154	Placebo n = 153
Value	4.85 (7.78)	6.98 (7.82)	7.76 (8.53)	-0.19 (5.31)

Udenafil 50 mg vs Placebo: Difference in Least Square (LS) Means: 5.04 (95% CI 3.36 to 6.73), p <0.0001, ANCOVA
Udenafil 100 mg vs Placebo: Difference in LS Means: 7.18 (95% CI 5.49 to 8.86), p <0.0001, ANCOVA
Udenafil 150mg vs Placebo: Difference in LS Means: 7.95 (95% CI 6.27 to 9.63), p <0.0001, ANCOVA

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

Primary outcome: 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. Least squares mean (95% Confidence Interval). Unit: Percentage Yes Responders

Measure	Udenafil 50 mg n = 150	Udenafil 100 mg n = 148	Udenafil 150mg n = 154	Placebo n = 153
Value	16.74 (11.71 to 21.78)	27.16 (22.13 to 32.18)	29.65 (24.71 to 34.60)	-1.86 (-6.88 to 3.16)

Udenafil 50 mg vs Placebo: Difference in LS Means: 18.60 (95% CI 11.72 to 25.48), p <0.0001, ANCOVA
Udenafil 100 mg vs Placebo: Difference in LS Means: 29.02 (95% CI 22.13 to 35.90), p <0.0001, ANCOVA
Udenafil 150mg vs Placebo: Difference in LS Means: 31.51 (95% CI 24.68 to 38.34), p <0.0001, ANCOVA

Population analysed: Modified Intent-to-Treat (mITT)

Primary outcome: Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT

Time frame: Baseline and Weeks 1 - 12. Least squares mean (95% Confidence Interval). Unit: Percentage Yes Responders

Measure	Udenafil 50 mg n = 150	Udenafil 100 mg n = 148	Udenafil 150mg n = 154	Placebo n = 153
Value	31.17 (25.85 to 36.50)	38.78 (33.46 to 44.10)	49.00 (43.76 to 54.23)	11.20 (5.87 to 16.52)

Udenafil 50 mg vs Placebo: Difference in LS Means: 19.98 (95% CI 12.69 to 27.26), p <0.0001, ANCOVA
Udenafil 100 mg vs Placebo: Difference in LS Means: 27.58 (95% CI 20.29 to 34.88), p <0.0001, ANCOVA
Udenafil 150mg vs Placebo: Difference in LS Means: 37.80 (95% CI 30.57 to 45.03), p <0.0001, ANCOVA

Population analysed: Modified Intent-to-Treat (mITT)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12-week treatment period. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Udenafil 50 mg	2 of 155 (1.3%)	43 of 155 (27.7%)	Not reported
Udenafil 100 mg	4 of 150 (2.7%)	57 of 150 (38%)	Not reported
Udenafil 150mg	1 of 159 (0.6%)	70 of 159 (44%)	Not reported
Placebo	2 of 152 (1.3%)	35 of 152 (23%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Erectile Dysfunction

RecruitingPhase 4
Assessment of the Value of FAPI and FDG-PET-CT in Diagnosis of Acute Phase Peyronie's Disease
Peyronie's Disease
RecruitingPhase 3
A Study to Evaluate Efficacy and Safety of HIP2602 in Erectile Dysfunction Patients
Erectile Dysfunction
RecruitingPhase 2
Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Prostate Cancer
Active, not recruiting
Efficacy of Low-dose Percutaneous Electrical Stimulation in Patients With Erectile Dysfunction.
Pudendal Nerve Injury, Erectile Dysfunction
Active, not recruiting
Treatment With Peripheral Nerve Stimulation of the Pudendal Nerve in Patients With Erectile Dysfunction
Erectile Dysfunction, Electric Stimulation

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

36 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 36 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 22 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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?

On the ClinicalTrials.gov record for NCT01037244.

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 22 Dec 2011.