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Clinical Trials/NCT04126252
NCT04126252CompletedNot Applicable

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

International Islamic University, Islamabad1 site in 1 country116 target enrollmentStarted: August 29, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
116
Locations
1
Primary Endpoint
International Index of Erectile Functioning-5

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Group A

Experimental

This arm received pharmacotherapy for erectile dysfunction.

Intervention: Sildenafil Citrate 50Mg Tab (Drug)

Group B

Experimental

This arm received cognitive behavior psychotherapy for erectile dysfunction.

Intervention: Cognitive Behavioral Psychotherapy (Behavioral)

Group C

Experimental

This arm received combined treatment approach.

Intervention: Combined or Integrated Therapy (Combination Product)

Group D

Placebo Comparator

This arm acted as a control group and received placebo or no intervention.

Intervention: Placebo (Other)

Outcomes

Primary Outcomes

International Index of Erectile Functioning-5

Time Frame: 3 months maximum

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmad Bilal

Principal Investigator, PhD Research Candidate

International Islamic University, Islamabad

Study Sites (1)

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