Erectile DysfunctionPhase 4NCT03169582
Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction
A Phase 4 study testing Avanafil and Sildenafil in people with Erectile Dysfunction, run by Eduardo Vargas-Baquero at 1 site in Spain.
Trial summary
The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal cord injury erectile dysfunction. The study has the characteristics of a non- inferiority, randomized, crossover, open clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Avanafil and Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2016to 1 Jun 2018
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spinal cord injury
- Erectile dysfunction
- No Medical Contraindication to use Avanafil and/or Sildenafil
- Able to provide informed consent
- Able to complete questionnaires
Who cannot join
- Medical Contraindication to use Avanafil and/or Sildenafil
- No spinal cord injury
- Congenital spinal cord injury
- Not able to provide informed consent
- Not able to complete questionnaires
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Nacional de Paraplejicos
Toledo, 45071
Eduardo Vargas-Baquero, MD
About this study
Official title: Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial
The main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal cord injury erectile dysfunction. The study has the characteristics of a non- inferiority, randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile Function Domain questionnaire of the International Index of Erectile Function IIEF).
This is an interventional study
- Conditions
- Erectile Dysfunction
- Being tested
- Avanafil, Sildenafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvanafilDrug
Also called no other interventions
Drug administration (Avanafil)
SildenafilDrug
Also called no other interventions
Drug administration (Sildenafil)
| Study group | Role | What they receive |
|---|---|---|
| Avanafil | Active comparator | Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil). Receives: Drug: Avanafil |
| Sildenafil | Active comparator | Clinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil) Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-EF
Erectile Function Domain questionnaire of the International Index of Erectile Function.
Measured: 2 years
Secondary outcomes (2)
SLQQ-Part II
Sexual life quality Questionnaire
Measured: 2 years
GAQ
Global Impression of efficacy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Apr 2016
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- non- inferiority, randomized, crossover, open clinical trial
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eduardo Vargas-Baquero
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eduardo Vargas-Baquero, Hospital Nacional de Parapléjicos de Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169582
- Sponsor's protocol ID
- HNParaplejicos
- Status last verified
- May 2017
- First submitted
- 21 Apr 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avanafil Versus Sildenafil in Spinal Cord Injury Erectile Dysfunction: Non- Inferiority, Randomized, Crossover, Open Clinical Trial
- ClinicalTrials.gov ID
- NCT03169582
- Acronym / sponsor ID
- HNParaplejicos
- Conditions
- Erectile Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Eduardo Vargas-BaqueroUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 30 May 2017 (actual)
- 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 main goal of this study is to compare the use of Avanafil versus Sildenafil in spinal cord injury erectile dysfunction. The study has the characteristics of a non- inferiority, randomized, crossover, open clinical trial. The principal variable is the IIEF-EF (Erectile Function Domain questionnaire of the International Index of Erectile Function IIEF).
This is an interventional study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- non- inferiority, randomized, crossover, open clinical trial
| Arm | Type | Receives |
|---|---|---|
| Avanafil | Active comparator | Drug: AvanafilClinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil). |
| Sildenafil | Active comparator | Drug: SildenafilClinical evaluation of the two pharmacological interventions (Sildenafil vs Avanafil) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Spinal cord injury
- Erectile dysfunction
- No Medical Contraindication to use Avanafil and/or Sildenafil
- Able to provide informed consent
- Able to complete questionnaires
Key exclusion criteria (5 listed)
- Medical Contraindication to use Avanafil and/or Sildenafil
- No spinal cord injury
- Congenital spinal cord injury
- Not able to provide informed consent
- Not able to complete questionnaires
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 |
|---|---|---|
| AvanafilAlso: no other interventionsDrug administration (Avanafil) | Drug | Avanafil |
| SildenafilAlso: no other interventionsDrug administration (Sildenafil) | Drug | Sildenafil |
Primary outcome
IIEF-EF
Time frame: 2 years
Erectile Function Domain questionnaire of the International Index of Erectile Function.
2 secondary outcomes
SLQQ-Part II
Time frame: 2 years
GAQ
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Individual participant dataSharing planned: No
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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.
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 Avanafil and Sildenafil in people with Erectile Dysfunction, run by Eduardo Vargas-Baquero at 1 site in Spain.
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 5 inclusion and 5 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 May 2017. 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 Spain. 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. 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 Eduardo Vargas-Baquero, MD (+34925247700 ext. 47748, edua33@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-EF (time frame: 2 years). 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 May 2017.