Erectile DysfunctionPhase 4NCT04374994
Daily Avanafil for Erectile Dysfunction
A Phase 4 study testing Avanafil 50 MG in people with Erectile Dysfunction, run by University of Alexandria at 1 site in Egypt.
Trial summary
In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo. 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 50 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 10 Oct 2019
- 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
- Men with clinical diagnosis of erectile dysfunction of any severity.
- Should be associated with systemic disorders indicative of endothelial dysfunction
Who cannot join
- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Alexandria University.
Alexandria, Elazareta, 21500
About this study
Official title: Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)
In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo.
Read the detailed description
Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor (PDE5-I) . However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the erectile function and endothelial markers' serum level. In this work we recruited males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction. The investigators randomly treated patients with daily oral avanafil and the other patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of markers of endothelial function at baseline and treatment.
- Conditions
- Erectile Dysfunction
- Being tested
- Avanafil 50 MG, Placebo oral tablet
- Keywords
- erectile dysfunction, endothelial dysfunction, Avanafil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avanafil 50 MGDrug
Oral phosphodiesterase type 5 inhibitors
Placebo oral tabletDrug
lactose and maize starch, Egypt
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | Males with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks Receives: Drug: Avanafil 50 MG |
| control group | Placebo comparator | Males with sexual dysfunction who received daily placebo tablets for four weeks Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of change of NO serum level from baseline to 4 weeks
To calculate the percentage of change of Nitric oxide (NO)(in µmol/L) serum level from baseline to 4 weeks post-treatment with avanafil
Measured: After 4 weeks treatment
The percentage of change of cGMP serum level from baseline to 4 weeks
To calculate the percentage of change of cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level from baseline to 4 weeks post-treatment with avanafil
Measured: After 4 weeks treatment
The percentage of change of ET1 serum level from baseline to 4 weeks
To calculate the percentage of change of endothelin-1 (ET1) (in ng/L) serum level from baseline to 4 weeks post-treatment with avanafil
Measured: After 4 weeks treatment
Secondary outcomes (3)
Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.
To compare avanafil with placebo group regarding post-treatment nitric oxide (NO) (in µmol/L) serum level and percentage of change from baseline.
Measured: After 4 weeks treatment
Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline.
To compare avanafil with placebo group regarding posttreatment cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level and percentage of change from baseline.
Measured: After 4 weeks treatment
Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline.
To compare avanafil with placebo group regarding post-treatment endothelin-1 (ET1) (in ng/L) serum level and percentage of change from baseline.
Measured: After 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start1 Sep 2018
- Primary completion15 Apr 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Ismail Abdelhamid, MD, University of Alexandria
- Investigators
- Abdelaal Elkamshoushi, MD, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374994
- Sponsor's protocol ID
- 0105643
- Status last verified
- Sep 2020
- First submitted
- 27 Apr 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because we will publish the study in a journal
Publications
Konstantinopoulos A, Giannitsas K, Athanasopoulos A, Spathas D, Perimenis P. The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction. Expert Opin Pharmacother. 2009 Feb;10(2):155-60. doi: 10.1517/14656560802678211.
PubMed 19236190
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Molecular Efficacy of Daily Avanafil in Egyptian Males With Erectile and Endothelial Dysfunction (Randomized Placebo-Controlled Study)
- ClinicalTrials.gov ID
- NCT04374994
- Acronym / sponsor ID
- 0105643
- Conditions
- Erectile Dysfunction
- Keywords
- erectile dysfunction, endothelial dysfunction, Avanafil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 5 May 2020 (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.
In this study, the investigators tried to study the effect of daily avanafil on the serum level of endothelial function markers, as well as its impact on the erectile function in males with erectile and endothelial dysfunction by comparing the results with controls who received placebo.
Detailed description
Avanafil is a highly selective and potent oral phosphodiesterase type 5 inhibitor (PDE5-I) . However, its impact on the soluble markers of endothelial function has not been investigated yet. This study was conducted to assess the effect of daily avanafil on the erectile function and endothelial markers' serum level. In this work we recruited males with erectile dysfunction and other diseases commonly associated with endothelial dysfunction. The investigators randomly treated patients with daily oral avanafil and the other patients with placebo. The investigators measured the International Index of Erectile Function -5 score (IIEF- 5) and the serum levels of markers of endothelial function at baseline and treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Drug: Avanafil 50 MGMales with sexual dysfunction who received daily avanafil tablets (50mg) for four weeks |
| control group | Placebo comparator | Drug: Placebo oral tabletMales with sexual dysfunction who received daily placebo tablets for four weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men with clinical diagnosis of erectile dysfunction of any severity.
- Should be associated with systemic disorders indicative of endothelial dysfunction
Key exclusion criteria (1 listed)
- Erectile dysfunction due to psychogenic causes, hypogonadism, or spinal cord injury.
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 |
|---|---|---|
| Avanafil 50 MGOral phosphodiesterase type 5 inhibitors | Drug | intervention group |
| Placebo oral tabletlactose and maize starch, Egypt | Drug | control group |
Primary outcome
The percentage of change of NO serum level from baseline to 4 weeks
Time frame: After 4 weeks treatment
To calculate the percentage of change of Nitric oxide (NO)(in µmol/L) serum level from baseline to 4 weeks post-treatment with avanafil
The percentage of change of cGMP serum level from baseline to 4 weeks
Time frame: After 4 weeks treatment
To calculate the percentage of change of cyclic guanosine monophosphate (cGMP) (in pmol/ml) serum level from baseline to 4 weeks post-treatment with avanafil
The percentage of change of ET1 serum level from baseline to 4 weeks
Time frame: After 4 weeks treatment
To calculate the percentage of change of endothelin-1 (ET1) (in ng/L) serum level from baseline to 4 weeks post-treatment with avanafil
3 secondary outcomes
Comparing avanafil with placebo group regarding post-treatment NO serum levels and percentage of change from baseline.
Time frame: After 4 weeks treatment
Comparing avanafil with placebo group regarding post-treatment cGMP serum levels and percentage of change from baseline.
Time frame: After 4 weeks treatment
Comparing avanafil with placebo group regarding post-treatment ET1 serum levels and percentage of change from baseline.
Time frame: After 4 weeks treatment
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 16 Sep 2020.
- Background: PubMed 19236190Konstantinopoulos A, Giannitsas K, Athanasopoulos A, Spathas D, Perimenis P. The impact of daily sildenafil on levels of soluble molecular markers of endothelial function in plasma in patients with erectile dysfunction. Expert Opin Pharmacother. 2009 Feb;10(2):155-60. doi: 10.1517/14656560802678211.
- Individual participant dataSharing planned: No. Because we will publish the study in a journal
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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.
Abdelaal Elkamshoushi, MD study director
University of Alexandria
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 50 MG in people with Erectile Dysfunction, run by University of Alexandria at 1 site in Egypt.
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 1 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 16 Sep 2020. 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 Egypt. 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?
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?
The percentage of change of NO serum level from baseline to 4 weeks (time frame: After 4 weeks treatment). The study lists 3 primary outcomes in all. 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 NCT04374994, which also lists 1 linked publication.
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 16 Sep 2020.