Erectile DysfunctionPhase 3NCT01305083
Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.
A Phase 3 study testing Udenafil in people with Erectile Dysfunction, run by Abdi Ibrahim Ilac San. ve Tic A.S. at 5 sites in Turkey (Türkiye).
Trial summary
This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Udenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- Oct 2010to Aug 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients of 18 to 60 years of age.
- Patients in a stable, monogamous sexual relationship with a female partner for at least 6 months and willing to maintain this relationship for the duration of the study.
- Patients with established diagnosis of erectile dysfunction (ED) of organic, psychogenic or mixed etiology for at least 6 months duration.
- Patient willing to attempt at least one sexual intercourse in a week for the entire treatment.
Who cannot join
- Patients with total erectile failure or any other sexual disorder such as hypoactive sexual desire.
- Patients who have previously failed to respond to PDE-5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
- Patients who have used other erectile dysfunction therapies within 14 days (2 weeks) prior to entering into this study (i.e. visit 1).
- Patients with hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or penile trauma.
- Patients with a history of major psychiatric disorder.
- Patients with a history of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease within the past 6 months.
Show all 16Show fewer
- Patients with a history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or a radical prostatectomy or radical pelvic surgery.
- Patients with hypotension (<90/50) or uncontrolled hypertension (>170/100), uncontrolled diabetes, hepatic impairment (SGOT or SGPT levels > 3 x Upper Normal Limit), renal impairment (serum creatinine > 2.5mg/dl), hematological disorders such as bleeding disorders.
- Patients with a history of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION).
- Patients with a history of sickle cell disease, multiple myeloma, leukemia or any other disorders that may cause priapism.
- Patients on concomitant treatment with nitrates/nitrites(NO) donor, CYP3A4 inhibitors, CYP3A4 inducers, anticoagulants, androgens, antiandrogens or trazodone.
- Patients with known hypersensitivity to PDE 5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
- Patient with known diagnosis to AIDS or with a positive HIV result at study screening visit.
- Patients with any other serious concurrent illness or malignancy.
- Patients with continuing history of alcohol and / or drug abuse.
- Participation in another clinical trial in the past 30days.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Turkey (Türkiye)5 sites
Study site
Ankara, 06100
Study site
Ankara
Study site
Istanbul
Study site
Izmir
Study site
Mersin, 33343
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Multicentric Study to Assess the Efficacy and Safety of Udenafil Tablets in Patients Suffering From Erectile Dysfunction.
This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED).
- 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
Placebo-control
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Udenafil | Active comparator | Active Ingredient Receives: Drug: Udenafil; Drug: Placebo |
| Placebo | Placebo comparator | Placebo Receives: Drug: Udenafil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF
Measured: 8 week
Secondary outcomes (3)
Changes in the total score of IIEF at the end of the treatment compared to baseline.
Measured: 8 week
Changes in score of Question 3 (SEP2) and Question 4 (SEP3) of IIEF questionnaire at the end of the treatment period as compared to baseline.
Measured: 8 week
Overall assessment of efficacy (GAQ) to the study medication at the end of the study.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2011
- Study completionAug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305083
- Sponsor's protocol ID
- AI2010-01
- Status last verified
- May 2012
- First submitted
- 25 Feb 2011
- Last updated
- 14 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Multicentric Study to Assess the Efficacy and Safety of Udenafil Tablets in Patients Suffering From Erectile Dysfunction.
- ClinicalTrials.gov ID
- NCT01305083
- Acronym / sponsor ID
- AI2010-01
- Conditions
- Erectile Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Abdi Ibrahim Ilac San. ve Tic A.S.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 28 Feb 2011 (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.
This randomized, double blind, placebo controlled, multicentric, clinical study will assess the efficacy and safety of Udenafil (100 mg) tablets in patients suffering from erectile dysfunction(ED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Udenafil | Active comparator | Drug: Udenafil, Drug: PlaceboActive Ingredient |
| Placebo | Placebo comparator | Drug: Udenafil, Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male patients of 18 to 60 years of age.
- Patients in a stable, monogamous sexual relationship with a female partner for at least 6 months and willing to maintain this relationship for the duration of the study.
- Patients with established diagnosis of erectile dysfunction (ED) of organic, psychogenic or mixed etiology for at least 6 months duration.
- Patient willing to attempt at least one sexual intercourse in a week for the entire treatment.
Key exclusion criteria (16 listed)
- Patients with total erectile failure or any other sexual disorder such as hypoactive sexual desire.
- Patients who have previously failed to respond to PDE-5 inhibitors like Sildenafil, Vardenafil or Tadalafil.
- Patients who have used other erectile dysfunction therapies within 14 days (2 weeks) prior to entering into this study (i.e. visit 1).
- Patients with hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie's disease or penile trauma.
- Patients with a history of major psychiatric disorder.
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 |
|---|---|---|
| UdenafilPlacebo-control | Drug | Placebo, Udenafil |
| PlaceboPlacebo | Drug | Placebo, Udenafil |
Primary outcome
IIEF
Time frame: 8 week
3 secondary outcomes
Changes in the total score of IIEF at the end of the treatment compared to baseline.
Time frame: 8 week
Changes in score of Question 3 (SEP2) and Question 4 (SEP3) of IIEF questionnaire at the end of the treatment period as compared to baseline.
Time frame: 8 week
Overall assessment of efficacy (GAQ) to the study medication at the end of the study.
Time frame: 8 week
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 14 May 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 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 Abdi Ibrahim Ilac San. ve Tic A.S. at 5 sites in Turkey (Türkiye).
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 16 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 14 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). 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?
IIEF (time frame: 8 week). 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 14 May 2012.