Erectile DysfunctionPhase 4SCINCT00725790
A Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
A Phase 4 study testing Vardenafil in people with Erectile Dysfunction, run by China Rehabilitation Research Center at 1 site in China.
Trial summary
The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a traumatic spinal cord injury Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Vardenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Sep 2009
- Phase
- Phase 4
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years old, had ED more than 6 months
- Traumatic spinal cord injury was the sole cause of ED
- Patients had been in a heterosexual relationship for at least 1 month
- Documented written informed consent.
Who cannot join
- Presence of symptomatic active urinary tract infection, indwelling urethral catheter.
- Patients who have used any kind of PDE-5i prior to the study
- Other conditions that may cause ED such as history of radical prostatectomy, diabetes mellitus, anatomic penile abnormality and primary hypoactive sexual desire
- History of symptomatic uncontrolled autonomic dysreflexia; postural hypotension
- Cardiovascular abnormality such as unstable angina pectoris, myocardial infarction or stroke, electrocardiographic ischemia or life-threatening arrhythmia, resting systolic blood pressure>170 or <90 mmHg, diastolic pressure >110mmHg
- Retinitis pigmentosa
- Patients who currently were using any of the following medications: nitrates, nitric oxide donors, androgen or antiandrogen, anticoagulants, trazodone, erythromycin, azole antifungals, other contraindicative medications in package insert
- Other contraindications in package insert
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Boai Hospital Affiliated to China Rehabilitation Research Center
Beijing, Beijing Municipality, 100077
Yan-He Ju, Dr., +86 010 87458636, jyhgjj@163.com
Li-Min Liao, Dr.
About this study
Official title: Multi-Centre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a traumatic spinal cord injury
Read the detailed description
According to the Massachusetts Male Aging Study, erectile dysfunction (ED) is estimated as affecting approximately 30 million American men and 100 million men worldwide. The study also reported that approximately 52% of males aged 40-70 experience some degree of ED. Prevalence has been shown to increase with age, with an estimated 40% of the responders experiencing ED at age 40, whereas, 67% had difficulties by age 75.
Considerable advances have been made since the NIH Consensus statement that defined ED as the persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance. However, one thing remains the same, sexuality continues to be a driving force in our society today. Many men with erectile dysfunction suffer from issues of self esteem, self worth, the creation and maintenance of interpersonal relationships and in general, wrestle with an overall altered sense of wellbeing. Damage to personal relationships can ensue; and the anger, depression, and anxiety engendered spill over into all aspects of life.
VIAGRA(sildenafil), administered as a flexible-dose regimen, has demonstrated to be an effective and well-tolerated treatment for ED in spinal cord injury sufferers.This is a multi-centre, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury.
- Conditions
- Erectile Dysfunction
- Being tested
- Vardenafil, Placebo
- Keywords
- Erectile Dysfunction, Spinal Cord Injury
- Medical subject headings
- Erectile Dysfunction, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
10 mg vardenafil on demand treatment for first 4 weeks.
A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period.
A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period.
PlaceboDrug
10 mg placebo on demand treatment for first 4 weeks.
A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period.
A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Vardenafil treatment group Receives: Drug: Vardenafil |
| B | Placebo comparator | Placebo treatment group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EF domain score of IIEF
Measured: week 12
Secondary outcomes (1)
IIEF/SEP/GAQ
Measured: at week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Rehabilitation Research Center
- Sponsor type
- Other government
- Investigators
- Li-Min Liao, Dr., Principal investigator, China Rehabilitation Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725790
- Sponsor's protocol ID
- SCI-01
- Acronym
- SCI
- Status last verified
- Jul 2008
- First submitted
- 28 Jul 2008
- Last updated
- 30 Jul 2008
- Results posted
- No
Publications
Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
PubMed 8254833Korenman SG. New insights into erectile dysfunction: a practical approach. Am J Med. 1998 Aug;105(2):135-44. doi: 10.1016/s0002-9343(98)00191-0.
PubMed 9727821
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centre, Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction Caused by Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT00725790
- Acronym / sponsor ID
- SCI / SCI-01
- Conditions
- Erectile Dysfunction
- Keywords
- Erectile Dysfunction, Spinal Cord Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- China Rehabilitation Research CenterOther government
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 30 Jul 2008 (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.
The purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to placebo in subjects with ED solely secondary to a traumatic spinal cord injury
Detailed description
According to the Massachusetts Male Aging Study, erectile dysfunction (ED) is estimated as affecting approximately 30 million American men and 100 million men worldwide. The study also reported that approximately 52% of males aged 40-70 experience some degree of ED. Prevalence has been shown to increase with age, with an estimated 40% of the responders experiencing ED at age 40, whereas, 67% had difficulties by age 75.
Considerable advances have been made since the NIH Consensus statement that defined ED as the persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance. However, one thing remains the same, sexuality continues to be a driving force in our society today. Many men with erectile dysfunction suffer from issues of self esteem, self worth, the creation and maintenance of interpersonal relationships and in general, wrestle with an overall altered sense of wellbeing. Damage to personal relationships can ensue; and the anger, depression, and anxiety engendered spill over into all aspects of life.
VIAGRA(sildenafil), administered as a flexible-dose regimen, has demonstrated to be an effective and well-tolerated treatment for ED in spinal cord injury sufferers.This is a multi-centre, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: VardenafilVardenafil treatment group |
| B | Placebo comparator | Drug: PlaceboPlacebo treatment group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old, had ED more than 6 months
- Traumatic spinal cord injury was the sole cause of ED
- Patients had been in a heterosexual relationship for at least 1 month
- Documented written informed consent.
Key exclusion criteria (8 listed)
- Presence of symptomatic active urinary tract infection, indwelling urethral catheter.
- Patients who have used any kind of PDE-5i prior to the study
- Other conditions that may cause ED such as history of radical prostatectomy, diabetes mellitus, anatomic penile abnormality and primary hypoactive sexual desire
- History of symptomatic uncontrolled autonomic dysreflexia; postural hypotension
- Cardiovascular abnormality such as unstable angina pectoris, myocardial infarction or stroke, electrocardiographic ischemia or life-threatening arrhythmia, resting systolic blood pressure>170 or <90 mmHg, diastolic pressure >110mmHg
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 |
|---|---|---|
| Vardenafil10 mg vardenafil on demand treatment for first 4 weeks. A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period. A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of vardenafil or down-titrate to 5 mg per dose of vardenafil during the subsequent 4 week double-blind treatment period. | Drug | A |
| Placebo10 mg placebo on demand treatment for first 4 weeks. A decision is made at week 4 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period. A decision is made at week 8 to either maintain the previous dosage regimen or to up-titrate to 20 mg per dose of placebo or down-titrate to 5 mg per dose of placebo during the subsequent 4 week double-blind treatment period. | Drug | B |
Primary outcome
EF domain score of IIEF
Time frame: week 12
1 secondary outcome
IIEF/SEP/GAQ
Time frame: at week 4, week 8, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
- Background: PubMed 8254833Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
- Background: PubMed 9727821Korenman SG. New insights into erectile dysfunction: a practical approach. Am J Med. 1998 Aug;105(2):135-44. doi: 10.1016/s0002-9343(98)00191-0.
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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.
Li-Min Liao, Dr. principal investigator
China Rehabilitation Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vardenafil in people with Erectile Dysfunction, run by China Rehabilitation Research Center at 1 site in China.
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 8 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: status not confirmed, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Min Liao, Dr. (+86 010 67563322 ext. 3702, lmliao@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EF domain score of IIEF (time frame: week 12). 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 NCT00725790, which also lists 2 linked publications.
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 Jul 2008.