Erectile DysfunctionPhase 1/2NCT04100759
A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers
A Phase 1/2 study testing Sildenafil 50 mg Oral Tablet in people with Erectile Dysfunction and Smoking, run by Ain Shams University at 1 site in Egypt.
Trial summary
Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction, Smoking, Pharmacokinetics
- What is being tested?
- Sildenafil 50 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2019to 8 Jul 2019
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subjects
- Age 18-55 years.
- Ideal weight with ideal body mass index(BMI).
- Non-contributory history and normal physiological examination.
- Laboratory data within normal limits.
- Performance and compliance.
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- The subjects should be without known history of alcohol or drug abuse problems
- Subjects who are cigarette smokers
- Subjects who are cannabis smokers
- Subjects who are non-smokers
Who cannot join
- A known hypersensitivity to the drug.
- Gastrointestinal diseases.
- Auto immune diseases.
- Renal diseases or dysfunction.
- Cardiovascular disease of any type.
- Pancreatic disease including diabetes.
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- Hepatic disease.
- Hematological, osteopathic, or pulmonary disease.
- History of alcoholism or drug abuse.
- Serious Psychological illness.
- Positive HIV.
- Abnormal (out of range) laboratory values.
- Subject who have taken any medication less than two weeks of the trials starting date.
- Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Sildenafil in Adult Smokers and Non-smokers
Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.
Read the detailed description
The study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (Cigarettes) and group(3) included twelve(12) healthy smokers (marijuana).
Each group received a single dose of Viagra 50 mg film coated tablet (Sildenafil 50 mg) Blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose.
Blood samples were centrifuged and plasma was separated and stored at -80 degree Celsius till time of analysis.
Plasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (LC/MS/MS)
- Conditions
- Erectile Dysfunction, Smoking, Pharmacokinetics, Pharmacodynamics
- Being tested
- Sildenafil 50 mg Oral Tablet
- Medical subject headings
- Erectile Dysfunction, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil 50 mg Oral TabletDrug
Also called Viagra 50 mg film coated tablets
Sildenafil 50 mg Oral Tablet
| Study group | Role | What they receive |
|---|---|---|
| Non-Smokers | Experimental | Subjects administer one tablet of sildenafil 50 mg Receives: Drug: Sildenafil 50 mg Oral Tablet |
| Cigarette Smokers | Experimental | Subjects administer one tablet of sildenafil 50mg Receives: Drug: Sildenafil 50 mg Oral Tablet |
| Cannabis Smokers | Experimental | Subjects administer one tablet of sildenafil 50mg Receives: Drug: Sildenafil 50 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration in plasma (Cmax)
Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)
Measured: up to 3 hours post-dose
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)
Area under the plasma concentration-time curve from time 0 to time(t) measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)
Measured: up to 24 hours post-dose
Secondary outcomes (3)
Time to Maximum drug concentration in plasma (tmax)
Time corresponding to maximum drug concentration in plasma measured in Hours(h)
Measured: up to 3 hours post-dose
Elimination half life of drug in plasma ( t½)
Elimination half life of drug measured in Hours(hr)
Measured: Up to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity
Area under the plasma concentration-time curve from time 0 to infinity measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)
Measured: Up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start11 Jun 2019
- Primary completion25 Jun 2019
- Study completion8 Jul 2019
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.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Drug Research Centre, Cairo, Egypt
- Responsible party
- Principal investigator, Mohamed Raslan, Drug Research Centre, Cairo, Egypt
- Investigators
- Nagwa A Sabri, phD, Principal investigator, Ainshams universityMohammed M Hussein, Msc student, Principal investigator, Ainshams universityMohamed A Raslan, Study director, Drug Research Centre, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100759
- Sponsor's protocol ID
- SIL-RES-0119
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2019
- Last updated
- 24 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Sildenafil in Adult Smokers and Non-smokers
- ClinicalTrials.gov ID
- NCT04100759
- Acronym / sponsor ID
- SIL-RES-0119
- Conditions
- Erectile Dysfunction, Smoking, Pharmacokinetics, Pharmacodynamics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Drug Research Centre, Cairo, Egypt
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 24 Sep 2019 (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.
Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.
Detailed description
The study is a randomized, single dose, one way, open label, parallel study in thirty-six (36) subjects randomized into three groups;group(1) included twelve(12) healthy non-smoker males, group(2) included twelve(12) healthy smokers (Cigarettes) and group(3) included twelve(12) healthy smokers (marijuana).
Each group received a single dose of Viagra 50 mg film coated tablet (Sildenafil 50 mg) Blood samples were collected at the following sampling intervals: pre-dose administration, 10 minutes, 20 minutes, 30 minutes, 45 minutes, 1, 1.5, 2, 3, 4, 6, 8,10, 12 and 24 hours post dose.
Blood samples were centrifuged and plasma was separated and stored at -80 degree Celsius till time of analysis.
Plasma concentrations of sildenafil were determined by liquid chromatography tandem mass spectrometry (LC/MS/MS)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Smokers | Experimental | Drug: Sildenafil 50 mg Oral TabletSubjects administer one tablet of sildenafil 50 mg |
| Cigarette Smokers | Experimental | Drug: Sildenafil 50 mg Oral TabletSubjects administer one tablet of sildenafil 50mg |
| Cannabis Smokers | Experimental | Drug: Sildenafil 50 mg Oral TabletSubjects administer one tablet of sildenafil 50mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male subjects
- Age 18-55 years.
- Ideal weight with ideal body mass index(BMI).
- Non-contributory history and normal physiological examination.
- Laboratory data within normal limits.
Key exclusion criteria (14 listed)
- A known hypersensitivity to the drug.
- Gastrointestinal diseases.
- Auto immune diseases.
- Renal diseases or dysfunction.
- Cardiovascular disease of any type.
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 |
|---|---|---|
| Sildenafil 50 mg Oral TabletAlso: Viagra 50 mg film coated tabletsSildenafil 50 mg Oral Tablet | Drug | Cannabis Smokers, Cigarette Smokers, Non-Smokers |
Primary outcome
Maximum drug concentration in plasma (Cmax)
Time frame: up to 3 hours post-dose
Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)
Time frame: up to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to time(t) measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)
3 secondary outcomes
Time to Maximum drug concentration in plasma (tmax)
Time frame: up to 3 hours post-dose
Elimination half life of drug in plasma ( t½)
Time frame: Up to 24 hours post-dose
Area under the plasma concentration-time curve from time 0 to infinity
Time frame: Up to 24 hours post-dose
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 24 Sep 2019.
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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.
Nagwa A Sabri, phD principal investigator
Ainshams university
Mohammed M Hussein, Msc student principal investigator
Ainshams university
Mohamed A Raslan study director
Drug Research Centre, Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sildenafil 50 mg Oral Tablet in people with Erectile Dysfunction and Smoking, run by Ain Shams University 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 10 inclusion and 14 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 24 Sep 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Maximum drug concentration in plasma (Cmax) (time frame: up to 3 hours post-dose). The study lists 2 primary outcomes in all. 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 24 Sep 2019.