Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

Erectile Dysfunction Clinical Trial

Official title:

A Comparison of Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126252
• Other study ID #: 0925-0586
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: September 3, 2019

Study information

• Verified date: November 2019
• Source: International Islamic University, Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Sildenafil Citrate 50Mg Tab
The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.

Behavioral:
• Cognitive Behavioral Psychotherapy
The Group B received cognitive behavior psychotherapy for a period of max 3 months.

Combination Product:
• Combined or Integrated Therapy
The Group C received the combined therapeutic approach for a period of max 3 months.

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

Locations

Country	Name	City	State
Pakistan	Ahmad Bilal Private Practice	Bahawalpur	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
International Islamic University, Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Index of Erectile Functioning-5		3 months maximum