SpermatogenesisPhase 1NCT01230541
Effect of Udenafil on Spermatogenesis
A Phase 1 study testing Udenafil in people with Spermatogenesis and Erectile Dysfunction, run by Warner Chilcott at 23 sites in United States.
Trial summary
Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics. Read more about this study
- Who is it for?
- Ages 25 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spermatogenesis, 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
- 239 participants
- Where
- 23 sitesUnited States
- Study dates
- Sep 2010to Nov 2011
- Phase
- Phase 1
- 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 25 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- No or mild ED (erectile dysfunction) willing \& able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 \& 26
- BMI (body mass index) between 19 and 31 kilogram/meter squared
Who cannot join
- New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest
- Nitrate medications for angina pectoris
- Used of anti-arrhythmic drug treatment or device
- Congestive heart failure
- Uncontrolled diabetes
- Stroke or transient ischemic attack (TIA) within last 6 months
Show all 9Show fewer
- Bleeding disorder or history of GI bleeding within last 12 months
- Cancer chemotherapy
- History of alcohol or drug abuse
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Warner Chilcott Investigational Site
Anaheim, California, 92801
Warner Chilcott Investigational Site
Atlanta, Georgia, 30342
Warner Chilcott Investigational Site
Aventura, Florida, 33180
Warner Chilcott Investigational Site
Cincinnati, Ohio, 45212
Warner Chilcott Investigational Site
Clearwater, Florida, 33759
Warner Chilcott Investigational Site
Doral, Florida, 33166
Warner Chilcott Investigational Site
Garden City, New York, 11530
Warner Chilcott Investigational Site
Great Neck, New York, 11021
Warner Chilcott Investigational Site
Huntsville, Alabama, 35801
Warner Chilcott Investigational Site
Middlebury, Connecticut, 06762
Warner Chilcott Investigational Site
Norfolk, Virginia, 23507
Warner Chilcott Investigational Site
Ocala, Florida, 34474
Warner Chilcott Investigational Site
Pinellas Park, Florida, 33782
Warner Chilcott Investigational Site
Plainsboro, New Jersey, 08536
Warner Chilcott Investigational Site
Purchase, New York, 10577
Warner Chilcott Investigational Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Site
San Diego, California, 92103
Warner Chilcott Investigational Site
San Diego, California, 92120
Warner Chilcott Investigational Site
Shreveport, Louisiana, 71115
Warner Chilcott Investigational Site
Spokane, Washington, 99204
Warner Chilcott Investigational Site
Tarzana, California, 91356
Warner Chilcott Investigational Site
Webster, Texas, 77598
Warner Chilcott Investigational Site
Williamsville, New York, 14221
About this study
Official title: Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.
Read the detailed description
Safety Study in male subjects with no or mild ED (erectile dysfunction)
- Conditions
- Spermatogenesis, Erectile Dysfunction
- Being tested
- Placebo, Udenafil
- Keywords
- Semen characteristics, Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Daily, oral tablet
UdenafilDrug
Daily tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Udenafil | Active comparator | Udenafil daily tablet Receives: Drug: Udenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm Concentration Reduction greater than or equal to 50% at Week 26
Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpermatogenesisStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 239 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
- NCT01230541
- Sponsor's protocol ID
- PR-00110
- Status last verified
- Nov 2011
- First submitted
- 27 Oct 2010
- Last updated
- 30 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Udenafil on Spermatogenesis: A Double-blind, Randomized, Placebo-controlled, Parallel-group Study
- ClinicalTrials.gov ID
- NCT01230541
- Acronym / sponsor ID
- PR-00110
- Conditions
- Spermatogenesis, Erectile Dysfunction
- Keywords
- Semen characteristics, Erectile Dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Oct 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.
Study of udenafil daily in subjects with mild or no erectile dysfunction to evaluate effects on semen characteristics.
Detailed description
Safety Study in male subjects with no or mild ED (erectile dysfunction)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Udenafil | Active comparator | Drug: UdenafilUdenafil daily tablet |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- No or mild ED (erectile dysfunction) willing \& able to provide 2 semen samples without the use of PDE-5 inhibitor or other excluded medication or devices on 2 separate days during screening and at Weeks 12 \& 26
- BMI (body mass index) between 19 and 31 kilogram/meter squared
Key exclusion criteria (9 listed)
- New onset coronary artery disease within last 3 months, history of myocardial infarction or cardiac surgical procedure within last 6 months or sudden cardiac arrest
- Nitrate medications for angina pectoris
- Used of anti-arrhythmic drug treatment or device
- Congestive heart failure
- Uncontrolled diabetes
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 |
|---|---|---|
| PlaceboDaily, oral tablet | Drug | Placebo |
| UdenafilDaily tablet | Drug | Udenafil |
Primary outcome
Sperm Concentration Reduction greater than or equal to 50% at Week 26
Time frame: 26 weeks
Percentage of Subjects with greater than or equal to 50% decrease from baseline in sperm concentration at 26 weeks
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 30 Nov 2011.
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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
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Udenafil in people with Spermatogenesis and Erectile Dysfunction, run by Warner Chilcott at 23 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 2 inclusion and 9 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 30 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Sperm Concentration Reduction greater than or equal to 50% at Week 26 (time frame: 26 weeks). 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 30 Nov 2011; AzTrials last refreshed its copy on 4 Nov 2026.