Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

NCT ID: NCT04126252

Last Updated: 2019-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2019-09-03

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

This arm received pharmacotherapy for erectile dysfunction.

Group Type EXPERIMENTAL

Sildenafil Citrate 50Mg Tab

Intervention Type DRUG

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

Group B

This arm received cognitive behavior psychotherapy for erectile dysfunction.

Group Type EXPERIMENTAL

Cognitive Behavioral Psychotherapy

Intervention Type BEHAVIORAL

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

Group C

This arm received combined treatment approach.

Group Type EXPERIMENTAL

Combined or Integrated Therapy

Intervention Type COMBINATION_PRODUCT

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

Group D

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Sildenafil Citrate 50Mg Tab

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

Intervention Type DRUG

Cognitive Behavioral Psychotherapy

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

Intervention Type BEHAVIORAL

Combined or Integrated Therapy

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

Intervention Type COMBINATION_PRODUCT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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International Islamic University, Islamabad

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Bilal

Principal Investigator, PhD Research Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmad Bilal

Role: PRINCIPAL_INVESTIGATOR

International Islamic University, Islamabad, Pakistan

Locations

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Ahmad Bilal Private Practice

Chak Eighty-seven -Twelve Left, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 36353027 (View on PubMed)

Other Identifiers

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0925-0586

Identifier Type: -

Identifier Source: org_study_id

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