Erectile DysfunctionPhase 3NCT01065012
Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
A Phase 3 study testing Udenafil 50 mg, Udenafil 100 mg and Udenafil 150 mg in people with Erectile Dysfunction, run by Warner Chilcott at 72 sites in United States.
Trial summary
Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 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 50 mg, Udenafil 100 mg and Udenafil 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,027 participants
- Where
- 72 sitesUnited States
- Study dates
- Jan 2010to Feb 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subject has completed Study PR-01209 or PR-01309
- Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
- Partner is not pregnant or lactating
Who cannot join
- Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
- 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
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
United States72 sites
Warner Chilcott Investigational Site
Arlington, Texas, 76017
Warner Chilcott Investigational Site
Aventura, Florida, 33180
Warner Chilcott Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Warner Chilcott Investigational Site
Bay Shore, New York, 11706
Warner Chilcott Investigational Site
Birmingham, Alabama, 35209
Warner Chilcott Investigational Site
Cary, North Carolina, 27518
Warner Chilcott Investigational Site
Chino, California, 91710
Warner Chilcott Investigational Site
Cincinnati, Ohio, 45212
Warner Chilcott Investigational Site
Clearwater, Florida, 33761
Warner Chilcott Investigational Site
Cleveland, Ohio, 44122
Warner Chilcott Investigational Site
Columbus, Georgia, 31904
Warner Chilcott Investigational Site
Concord, North Carolina, 28025
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
Denver, Colorado, 80211
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
Garden City, New York, 11530
Warner Chilcott Investigational Site
Greenwood, Indiana, 46143
Warner Chilcott Investigational Site
Greer, South Carolina, 29650
Warner Chilcott Investigational Site
Harrisburg, North Carolina, 28075
Warner Chilcott Investigational Site
Homewood, Alabama, 35209
Warner Chilcott Investigational Site
Huntsville, Alabama, 35801
Warner Chilcott Investigational Site
Jeffersonville, Indiana, 47130
Warner Chilcott Investigational Site
Jenkintown, Pennsylvania, 19046
Warner Chilcott Investigational Site
Kingston, New York, 12401
Warner Chilcott Investigational Site
Laguna Hills, California, 92653
Warner Chilcott Investigational Site
Lancaster, Pennsylvania, 17604
Warner Chilcott Investigational Site
Las Vegas, Nevada, 89106
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, 08648
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
Milford, Connecticut, 06460
Warner Chilcott Investigational Site
Mountlake Terrace, Washington, 98043
Warner Chilcott Investigational Site
Mt. Pleasant, South Carolina, 29464
Warner Chilcott Investigational Site
Myrtle Beach, South Carolina, 29572
Warner Chilcott Investigative 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
Norfolk, Virginia, 23502
Warner Chilcott Investigational Site
Ocala, Florida, 34471
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
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
Rochester, New York, 14609
Warner Chilcott Investigational Site
Salisbury, North Carolina, 28144
Warner Chilcott Investigational Site
Salt Lake City, Utah, 84107
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Site
San Diego, California, 92103
Warner Chilcott Investigational Site
Sandy Springs, Georgia, 30328
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
Tampa, Florida, 33607
Warner Chilcott Investigational Site
Tarzana, California, 91356
Warner Chilcott Investigational Site
Tempe, Arizona, 85282
Warner Chilcott Investigative Site
Torrance, California, 90505
Warner Chilcott Investigational Site
Tucson, Arizona, 85741
Warner Chilcott Investigational Site
Waterbury, Connecticut, 06708
Warner Chilcott Investigational Site
West Des Moines, Iowa, 50266
Warner Chilcott Investigational Site
Williamsville, New York, 14221
Warner Chilcott Investigational Site
Wilmington, North Carolina, 28401
Warner Chilcott Investigative Site
Wilmington, North Carolina, 28401
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, 27103
About this study
Official title: Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).
Read the detailed description
Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.
- Conditions
- Erectile Dysfunction
- Being tested
- Udenafil 50 mg, Udenafil 100 mg, Udenafil 150 mg, Placebo Matching 50 mg Udenafil, Placebo Matching 100 mg Udenafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Udenafil 50 mgDrug
Also called WC3043
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Udenafil 100 mgDrug
Also called WC3043
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Udenafil 150 mgDrug
Also called WC3043
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 50 mg UdenafilDrug
Also called Placebo 50 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 100 mg UdenafilDrug
Also called Placebo 100 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 150 mg UdenafilDrug
Also called Placebo 150 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
| Study group | Role | What they receive |
|---|---|---|
| Udenafil 50 mg | Experimental | 50 mg Udenafil Receives: Drug: Udenafil 50 mg; Drug: Placebo Matching 100 mg Udenafil; Drug: Placebo Matching 150 mg Udenafil |
| Udenafil 100 mg | Experimental | 100 mg Udenafil Receives: Drug: Udenafil 100 mg; Drug: Placebo Matching 50 mg Udenafil; Drug: Placebo Matching 150 mg Udenafil |
| Udenafil 150 mg | Experimental | 150 mg Udenafil Receives: Drug: Udenafil 150 mg; Drug: Placebo Matching 50 mg Udenafil; Drug: Placebo Matching 100 mg Udenafil |
| Placebo | Placebo comparator | Placebo Tablets matching Udenafil tablets Receives: Drug: Placebo Matching 50 mg Udenafil; Drug: Placebo Matching 100 mg Udenafil; Drug: Placebo Matching 150 mg Udenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function (IIEF) score
Measured: Assessment will be made after each use of the study drug over a 36 week use period.
Secondary outcomes (1)
Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction
Measured: Assessment will be made after each use of the study drug over a 36 week use period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,027 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
- NCT01065012
- Sponsor's protocol ID
- PR-01409
- Status last verified
- Mar 2015
- First submitted
- 5 Feb 2010
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
- ClinicalTrials.gov ID
- NCT01065012
- Acronym / sponsor ID
- PR-01409
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,027 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).
Detailed description
Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Udenafil 50 mg | Experimental | Drug: Udenafil 50 mg, Drug: Placebo Matching 100 mg Udenafil, Drug: Placebo Matching 150 mg Udenafil50 mg Udenafil |
| Udenafil 100 mg | Experimental | Drug: Udenafil 100 mg, Drug: Placebo Matching 50 mg Udenafil, Drug: Placebo Matching 150 mg Udenafil100 mg Udenafil |
| Udenafil 150 mg | Experimental | Drug: Udenafil 150 mg, Drug: Placebo Matching 50 mg Udenafil, Drug: Placebo Matching 100 mg Udenafil150 mg Udenafil |
| Placebo | Placebo comparator | Drug: Placebo Matching 50 mg Udenafil, Drug: Placebo Matching 100 mg Udenafil, Drug: Placebo Matching 150 mg UdenafilPlacebo Tablets matching Udenafil tablets |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject has completed Study PR-01209 or PR-01309
- Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
- Partner is not pregnant or lactating
Key exclusion criteria (6 listed)
- Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
- 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 |
|---|---|---|
| Udenafil 50 mgAlso: WC3043Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject. | Drug | Udenafil 50 mg |
| Udenafil 100 mgAlso: WC3043Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject. | Drug | Udenafil 100 mg |
| Udenafil 150 mgAlso: WC3043Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject. | Drug | Udenafil 150 mg |
| Placebo Matching 50 mg UdenafilAlso: Placebo 50 mgTablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject. | Drug | Placebo, Udenafil 100 mg, Udenafil 150 mg |
| Placebo Matching 100 mg UdenafilAlso: Placebo 100 mgTablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject. | Drug | Placebo, Udenafil 150 mg, Udenafil 50 mg |
| Placebo Matching 150 mg UdenafilAlso: Placebo 150 mgTablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject. | Drug | Placebo, Udenafil 100 mg, Udenafil 50 mg |
Primary outcome
International Index of Erectile Function (IIEF) score
Time frame: Assessment will be made after each use of the study drug over a 36 week use period.
1 secondary outcome
Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction
Time frame: Assessment will be made after each use of the study drug over a 36 week use period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
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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
72 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 50 mg, Udenafil 100 mg and Udenafil 150 mg in people with Erectile Dysfunction, run by Warner Chilcott at 72 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 3 inclusion and 6 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 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
International Index of Erectile Function (IIEF) score (time frame: Assessment will be made after each use of the study drug over a 36 week use period.). 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 20 Apr 2015.