Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

NCT04126252 | Completed DMC

• 1 other identifier: 0925-0586
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Functioning-5

  3 months maximum

Study Arms (4)

Group A

EXPERIMENTAL

This arm received pharmacotherapy for erectile dysfunction.

Drug: Sildenafil Citrate 50Mg Tab

Group B

EXPERIMENTAL

This arm received cognitive behavior psychotherapy for erectile dysfunction.

Behavioral: Cognitive Behavioral Psychotherapy

Group C

EXPERIMENTAL

This arm received combined treatment approach.

Combination Product: Combined or Integrated Therapy

Group D

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Sildenafil Citrate 50Mg Tab DRUG

The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.

Group A

Cognitive Behavioral Psychotherapy BEHAVIORAL

The Group B received cognitive behavior psychotherapy for a period of max 3 months.

Group B

Combined or Integrated Therapy COMBINATION_PRODUCT

The Group C received the combined therapeutic approach for a period of max 3 months.

Group C

Placebo OTHER

The Group D received no treatment or placebo for a period of max 3 months.

Group D

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Males
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Islamic University, Islamabad: lead

Study Sites (1)

Ahmad Bilal Private Practice

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

Location

Related Publications (1)

• Bilal A, Abbasi NUH. Development of an indigenous manual of cognitive behavior sex therapy for young men. J Family Med Prim Care. 2022 Aug;11(8):4127-4130. doi: 10.4103/jfmpc.jfmpc_1892_21. Epub 2022 Aug 30.

  PMID: 36353027 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmad Bilal

  International Islamic University, Islamabad, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Research Candidate

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: August 29, 2018
• Primary Completion: September 3, 2019
• Study Completion: September 3, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Locations

PA (1)