Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

November 28, 2019 updated by: Ahmad Bilal, International Islamic University, Islamabad

A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy to individuals suffering from erectile dysfunction. The study was randomized controlled trial with four arms involving a control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Bahāwalpur, Punjab, Pakistan, 63100
        • Ahmad Bilal Private Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men diagnosed with erectile dysfunction
  • Must be in the age range of 18 to 40 years
  • Must be in a stable heterosexual relationship
  • Must not be suffering from any medical or psychiatric illness

Exclusion Criteria:

  • Men not meeting criteria of diagnosis of erectile dysfunction
  • Men not in a heterosexual relationship
  • Men above the age of 40 years
  • Men diagnosed with any medical or psychiatric illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
This arm received pharmacotherapy for erectile dysfunction.
Drug: Sildenafil Citrate 50Mg Tab
The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.
Experimental: Group B
This arm received cognitive behavior psychotherapy for erectile dysfunction.
Behavioral: Cognitive Behavioral Psychotherapy
The Group B received cognitive behavior psychotherapy for a period of max 3 months.
Experimental: Group C
This arm received combined treatment approach.
Combination product: Combined or Integrated Therapy
The Group C received the combined therapeutic approach for a period of max 3 months.
Placebo Comparator: Group D
This arm acted as a control group and received placebo or no intervention.
Other: Placebo
The Group D received no treatment or placebo for a period of max 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Index of Erectile Functioning-5
Time Frame: 3 months maximum
3 months maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Islamic University, Islamabad

Investigators

  • Principal Investigator: Ahmad Bilal, International Islamic University, Islamabad, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2018

Primary Completion (Actual)

September 3, 2019

Study Completion (Actual)

September 3, 2019

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

December 2, 2019

Last Update Submitted That Met QC Criteria

November 28, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0925-0586

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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