NCT04179747

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 two arms involving a control group. The study was conducted with an aim of pilot and feasibility study to evaluate the efficacy and suitability of cognitive behavior psychotherapy with individuals suffering from erectile dysfunction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 18, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

6 months

First QC Date

November 24, 2019

Last Update Submit

November 26, 2019

Conditions

Erectile Dysfunction

Keywords

Sexual Dysfunctions, Men Health

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Functioning-5

    The minimum scale score is 5. The maximum scale score is 25. The higher score indicates better erectile functioning.

    3 months maximum

Secondary Outcomes (1)

  • Depression, Anxiety, and Stress Scale-21

    3 months maximum

Study Arms (2)

Group A

EXPERIMENTAL

The cognitive behavior psychotherapy was administered to participants in this treatment arm.

Behavioral: Cognitive Behavioral Psychotherapy

Control Group

ACTIVE COMPARATOR

This group received the administration of pharmacotherapy (PDE5i) for treatment of Erectile Dysfunction.

Drug: Sildenafil Citrate 50Mg Tab

Interventions

Cognitive Behavioral PsychotherapyBEHAVIORAL

The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.

Also known as: Cognitive Behavior Psychotherapy
Group A
Sildenafil Citrate 50Mg TabDRUG

The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.

Also known as: PDE5i
Control Group

Eligibility Criteria

Age18 Years - 39 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Men diagnosed with erectile dysfunction
  • Must be in the age range of 18 to 39 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 of or above the age of 40 years
  • Men diagnosed with any medical or psychiatric illness or obese men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmad Bilal Private Practice

Chak Four Hundred Fifty-four, South Punjab, 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: 36353027DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Cognitive Behavioral TherapySildenafil Citrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Ahmad Bilal, MPhil

    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

November 24, 2019

First Posted

November 27, 2019

Study Start

January 18, 2018

Primary Completion

July 24, 2018

Study Completion

July 24, 2018

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)