Back to resultsPharmacotherapy 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
About this trial
This is an interventional other trial for Erectile Dysfunction
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
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
NCT ID
NCT04126252
First Posted
October 11, 2019
Last Updated
November 28, 2019
Sponsor
International Islamic University, Islamabad
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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