Erectile DysfunctionNCT04623840
Combined Effect of Continuous and Interval in Addition to Tadalafil Drug on Erectile Dysfunction
A study testing Tadalafil 5Mg Tab + continuous and interval exercise and Tadalafil 5Mg Tab in people with Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
Erectile dysfunction (ED) is the persistent inability to attain and maintain a sufficient erection to permit satisfactory sexual performance. ED, a condition closely related to cardiovascular morbidity and mortality, is frequently associated with obesity. Read more about this study
- Who is it for?
- Ages 40 to 50 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Tadalafil 5Mg Tab + continuous and interval exercise and Tadalafil 5Mg Tab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2020to 30 Mar 2021
- Phase
- Interventional
- 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 40 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Sixty sedentary obese married men with BMI > 30 kg/m2.
- The age of participants will range from 40-50 years old.
- Blood pressure will be < 140/90 mm Hg.
- The patients who will have ED at least from 6 months with IIEF-5 score < 22.
Who cannot join
- Alcoholic, smoker, hypertensive, diabetic, and addicted patients.
- Patients with pulmonary, renal, hepatic, and cardiac disorders.
- Lower limb arthritis or orthopaedic disorders that will hinder the training program.
- Prostatic inflammation, hyperplasia, and tumors.
- Participation in a structured sport program in the previous 6 months.
- previous pelvic and genital surgeries.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: Obesity-induced ED Response to Combined Effect of Tadalafil Drug in Addition to Interval and Continuous Training
Erectile dysfunction (ED) is the persistent inability to attain and maintain a sufficient erection to permit satisfactory sexual performance. ED, a condition closely related to cardiovascular morbidity and mortality, is frequently associated with obesity. The importance of reducing cardiovascular risk factors remains fundamental to the overall vascular good health of the man, and that includes sexual vascular health. ED shares similar modifiable risks factors with coronary artery disease (CAD). Lifestyle modification that targets CAD risk factors may also lead to improvement in ED.
Read the detailed description
Sixty obese men with ED complaints will be divided to two groups, exercised and non-exercised groups; n= 30 patients in every group. Both groups will receive five milligrams of tadalafil one time per day for 8 weeks but the exercised group only will receive - in addition to tadalafil - combined continuous and interval aerobic training, 3 session weekly for 8 weeks after detecting their target heart rate via the cardiopulmonary exercise test.
- Conditions
- Erectile Dysfunction
- Being tested
- Tadalafil 5Mg Tab + continuous and interval exercise, Tadalafil 5Mg Tab
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5Mg Tab + continuous and interval exerciseOther
Also called group 1
(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks
Tadalafil 5Mg TabDrug
Also called group 2
(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Exercised group | Experimental | .(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks Receives: Other: Tadalafil 5Mg Tab + continuous and interval exercise |
| non-exercised group | Active comparator | (n=30) will be sedentary obese men with ED. All participants will receive only five milligrams of tadalafil, one time per day, for eight weeks. Receives: Drug: Tadalafil 5Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five-Item Version of International Index of Erectile Function (IIEF-5)
It is a questionnaire of five questions to diagnose ED in male patients
Measured: It will be measured after eight weeks of training
Secondary outcomes (9)
Triglycerides
It will be measured via a venous blood sample
Measured: It will be measured after eight weeks of training
High density lipoprotein
It will be measured via a venous blood sample
Measured: It will be measured after eight weeks of training
Insulin
It will be measured via a venous blood sample
Measured: It will be measured after eight weeks of training
Fasting blood glucose
it will be measured via a blood glucose meter
Measured: It will be measured after eight weeks of training
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
HOMA-IR = [fasting insulin (μU/mL)
× fasting glucose (mmol)]/22.5
Measured: It will be measured after eight weeks of training
body mass index
It will be obtained by dividing the weight in Kilograms on the squared height in meter
Measured: It will be measured after eight weeks of training
systolic blood pressure
it will be measured by a manual sphygmomanometer
Measured: It will be measured after eight weeks of training
diastolic blood pressure
it will be measured by a manual sphygmomanometer
Measured: It will be measured after eight weeks of training
Waist circumference
it will be measured by inelastic tape at the umbilicus level
Measured: It will be measured after eight weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start12 Oct 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Mar 2021 (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.
- More trials run by Cairo 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623840
- Sponsor's protocol ID
- P.T.REC/012/002918
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 10 Nov 2020
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity-induced ED Response to Combined Effect of Tadalafil Drug in Addition to Interval and Continuous Training
- ClinicalTrials.gov ID
- NCT04623840
- Acronym / sponsor ID
- P.T.REC/012/002918
- Conditions
- Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 10 Nov 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.
Erectile dysfunction (ED) is the persistent inability to attain and maintain a sufficient erection to permit satisfactory sexual performance. ED, a condition closely related to cardiovascular morbidity and mortality, is frequently associated with obesity. The importance of reducing cardiovascular risk factors remains fundamental to the overall vascular good health of the man, and that includes sexual vascular health. ED shares similar modifiable risks factors with coronary artery disease (CAD). Lifestyle modification that targets CAD risk factors may also lead to improvement in ED.
Detailed description
Sixty obese men with ED complaints will be divided to two groups, exercised and non-exercised groups; n= 30 patients in every group. Both groups will receive five milligrams of tadalafil one time per day for 8 weeks but the exercised group only will receive - in addition to tadalafil - combined continuous and interval aerobic training, 3 session weekly for 8 weeks after detecting their target heart rate via the cardiopulmonary exercise test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercised group | Experimental | Other: Tadalafil 5Mg Tab + continuous and interval exercise.(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks |
| non-exercised group | Active comparator | Drug: Tadalafil 5Mg Tab(n=30) will be sedentary obese men with ED. All participants will receive only five milligrams of tadalafil, one time per day, for eight weeks. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sixty sedentary obese married men with BMI > 30 kg/m2.
- The age of participants will range from 40-50 years old.
- Blood pressure will be < 140/90 mm Hg.
- The patients who will have ED at least from 6 months with IIEF-5 score < 22.
Key exclusion criteria (6 listed)
- Alcoholic, smoker, hypertensive, diabetic, and addicted patients.
- Patients with pulmonary, renal, hepatic, and cardiac disorders.
- Lower limb arthritis or orthopaedic disorders that will hinder the training program.
- Prostatic inflammation, hyperplasia, and tumors.
- Participation in a structured sport program in the previous 6 months.
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 |
|---|---|---|
| Tadalafil 5Mg Tab + continuous and interval exerciseAlso: group 1(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks | Other | Exercised group |
| Tadalafil 5Mg TabAlso: group 2(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks | Drug | non-exercised group |
Primary outcome
Five-Item Version of International Index of Erectile Function (IIEF-5)
Time frame: It will be measured after eight weeks of training
It is a questionnaire of five questions to diagnose ED in male patients
9 secondary outcomes
Triglycerides
Time frame: It will be measured after eight weeks of training
High density lipoprotein
Time frame: It will be measured after eight weeks of training
Insulin
Time frame: It will be measured after eight weeks of training
Fasting blood glucose
Time frame: It will be measured after eight weeks of training
The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance
Time frame: It will be measured after eight weeks of training
body mass index
Time frame: It will be measured after eight weeks of training
systolic blood pressure
Time frame: It will be measured after eight weeks of training
diastolic blood pressure
Time frame: It will be measured after eight weeks of training
Waist circumference
Time frame: It will be measured after eight weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Related trials for Erectile Dysfunction
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Recruiting
Platelet-Rich Plasma for Erectile Dysfunction After Radical Prostatectomy
Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction
Not yet recruiting
Erectile Function PRESERVation in Definitive Radiotherapy for Prostate Cancer by MRI-Enhanced Adaptive Sparing of the Neurovascular Bundle
Prostate Cancer, Localized Prostate Carcinoma
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
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.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tadalafil 5Mg Tab + continuous and interval exercise and Tadalafil 5Mg Tab in people with Erectile Dysfunction, run by Cairo 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 4 inclusion and 6 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 10 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-Item Version of International Index of Erectile Function (IIEF-5) (time frame: It will be measured after eight weeks of training). 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 10 Nov 2020.