NCT04623840

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 4, 2020

Last Update Submit

November 9, 2020

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Five-Item Version of International Index of Erectile Function (IIEF-5)

    It is a questionnaire of five questions to diagnose ED in male patients

    It will be measured after eight weeks of training

Secondary Outcomes (9)

  • Triglycerides

    It will be measured after eight weeks of training

  • High density lipoprotein

    It will be measured after eight weeks of training

  • Insulin

    It will be measured after eight weeks of training

  • Fasting blood glucose

    It will be measured after eight weeks of training

  • The HOMA-IR (Homeostatic Model Assessment for Insulin Resistance

    It will be measured after eight weeks of training

  • +4 more secondary outcomes

Study Arms (2)

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

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.

Drug: Tadalafil 5Mg Tab

Interventions

Tadalafil 5Mg Tab + continuous and interval exerciseOTHER

(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

Also known as: group 1
Exercised group
Tadalafil 5Mg TabDRUG

(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks

Also known as: group 2
non-exercised group

Eligibility Criteria

Age40 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

CarbolinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

October 12, 2020

Primary Completion

February 28, 2021

Study Completion

March 30, 2021

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

EG(1)