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Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sildenafil Citrate 50Mg Tab
Cognitive Behavioral Psychotherapy
Combined or Integrated Therapy
Placebo
Sponsored by
International Islamic University, Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ahmad Bilal Private Practice

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

This arm received pharmacotherapy for erectile dysfunction.

This arm received cognitive behavior psychotherapy for erectile dysfunction.

This arm received combined treatment approach.

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

Outcomes

Primary Outcome Measures

International Index of Erectile Functioning-5

Secondary Outcome Measures

Full Information

First Posted
October 11, 2019
Last Updated
November 28, 2019
Sponsor
International Islamic University, Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT04126252
Brief Title
Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
Official Title
A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 29, 2018 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Islamic University, Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
This arm received pharmacotherapy for erectile dysfunction.
Arm Title
Group B
Arm Type
Experimental
Arm Description
This arm received cognitive behavior psychotherapy for erectile dysfunction.
Arm Title
Group C
Arm Type
Experimental
Arm Description
This arm received combined treatment approach.
Arm Title
Group D
Arm Type
Placebo Comparator
Arm Description
This arm acted as a control group and received placebo or no intervention.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate 50Mg Tab
Intervention Description
The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Psychotherapy
Intervention Description
The Group B received cognitive behavior psychotherapy for a period of max 3 months.
Intervention Type
Combination Product
Intervention Name(s)
Combined or Integrated Therapy
Intervention Description
The Group C received the combined therapeutic approach for a period of max 3 months.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The Group D received no treatment or placebo for a period of max 3 months.
Primary Outcome Measure Information:
Title
International Index of Erectile Functioning-5
Time Frame
3 months maximum

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad Bilal
Organizational Affiliation
International Islamic University, Islamabad, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahmad Bilal Private Practice
City
Bahāwalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan

12. IPD Sharing Statement

Citations:
PubMed Identifier
36353027
Citation
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.
Results Reference
derived

Learn more about this trial

Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

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