Erectile DysfunctionNCT03033537
Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Adam International Hospital.
Trial summary
Introduction: Erectile dysfunction is a common condition with a significant effect on quality of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes the tone of the smooth muscles lining blood vessels, leading to their dilatation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Verapamil
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 20 Jan 2016
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: Males complaining of erectile dysfunction
Who may be able to join
- Married male patients suffering from erectile dysfunction and scheduled for intracavernosal injection.
Who cannot join
- Responders to PDE5-inhibitors; congenital or acquired penile anomalies; uncontrolled medical conditions or known hypersensitivity to verapamil; Peyronie's disease and any known bleeding or coagulation disorders.
About this study
Official title: Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction: A Pilot Study
Introduction: Erectile dysfunction is a common condition with a significant effect on quality of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes the tone of the smooth muscles lining blood vessels, leading to their dilatation.
Read the detailed description
Objective: Evaluating the effect of intracavernosal injection of (Papaverine + Verapamil) and comparing it with (Papaverine + Phentolamine) in patients with erectile dysfunction.
Patients and methods: Each one of the 20 erectile dysfunction patients was subjected to intracavernosal injection with (30mg Papaverine + 1mg Phentolamine), where penile duplex \& clinical evaluation was carried out followed by a wash out interval of 2 weeks after which each patient was subjected to the exact previous procedures using (30 mg Papaverine + 5 mg Verapamil).
Keywords: Erectile dysfunction - Intracavernosal injection - Penile duplex - Phentolamine - Verapamil.
- Conditions
- Erectile Dysfunction
- Being tested
- Verapamil
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Also called Calcium Channel Blocker
Local treatment of erectile dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Intracavernosal injection of Verapamil Receives: Drug: Verapamil | |
| Phentolamine | Intracavernosal injection of Phentolamine to treat erectile dysfunction for a period of 2 wweks Receives: Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF5
Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Jul 2015
- Primary completion1 Jan 2016
- Study completion20 Jan 2016
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Adam International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Raef Sadek, Adam International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033537
- Sponsor's protocol ID
- 2016
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- 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 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracavernosal Injection of Papaverine/Verapamil Versus Papaverine/Phentolamine in Erectile Dysfunction: A Pilot Study
- ClinicalTrials.gov ID
- NCT03033537
- Acronym / sponsor ID
- 2016
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Adam International HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 20 Jan 2016 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
Introduction: Erectile dysfunction is a common condition with a significant effect on quality of life. Verapamil is calcium channel blocker of the phenyl alkylamine class which relaxes the tone of the smooth muscles lining blood vessels, leading to their dilatation.
Detailed description
Objective: Evaluating the effect of intracavernosal injection of (Papaverine + Verapamil) and comparing it with (Papaverine + Phentolamine) in patients with erectile dysfunction.
Patients and methods: Each one of the 20 erectile dysfunction patients was subjected to intracavernosal injection with (30mg Papaverine + 1mg Phentolamine), where penile duplex \& clinical evaluation was carried out followed by a wash out interval of 2 weeks after which each patient was subjected to the exact previous procedures using (30 mg Papaverine + 5 mg Verapamil).
Keywords: Erectile dysfunction - Intracavernosal injection - Penile duplex - Phentolamine - Verapamil.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil | – | Drug: VerapamilIntracavernosal injection of Verapamil |
| Phentolamine | – | Drug: VerapamilIntracavernosal injection of Phentolamine to treat erectile dysfunction for a period of 2 wweks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Males complaining of erectile dysfunction
Key inclusion criteria (1 listed)
- Married male patients suffering from erectile dysfunction and scheduled for intracavernosal injection.
Key exclusion criteria (1 listed)
- Responders to PDE5-inhibitors; congenital or acquired penile anomalies; uncontrolled medical conditions or known hypersensitivity to verapamil; Peyronie's disease and any known bleeding or coagulation disorders.
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 |
|---|---|---|
| VerapamilAlso: Calcium Channel BlockerLocal treatment of erectile dysfunction | Drug | Phentolamine, Verapamil |
Primary outcome
IIEF5
Time frame: 6 months
Questionnaire
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 27 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Adam International Hospital.
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 1 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 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
IIEF5 (time frame: 6 months). 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 27 Jan 2017.