NCT07356609

Brief Summary

The PERFORM registry is a structured, real-world data platform designed to systematically capture patient characteristics, disease severity and treatment patterns of Erectile Dysfunction (ED) across Pakistan. By reflecting routine clinical practice, an ED registry provides valuable insights into the disease epidemiology, unmet needs, and variations in care across populations. It supports evidence-based decision-making, helps identifying early predictors, and inform guideline development, health policy, and personalized management strategies in male sexual health.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
255

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Feb 2026

Status
not yet recruiting

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 Progress19%
Feb 2026May 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 8, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

Erectile dysfunctionmale reproductive healthmale sexual health

Outcome Measures

Primary Outcomes (2)

  • Descriptive data of frequency, severity of ED in Pakistan

    Prevalence

    Baseline

  • Descriptive data [age, income (derivative of socio-economic class), rural/urban population and occupation]

    Demographics

    baseline

Secondary Outcomes (2)

  • Age of diabetes in ED patients

    baseline

  • Duration of ED

    baseline

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult Male ED patients

You may qualify if:

  • Adult male above 18 years of age
  • Married
  • Diabetic
  • Patient reports erectile dysfunction (symptomatic).
  • Patient is eligible to be prescribed sildenafil by treating clinician.

You may not qualify if:

  • If at any other PDE-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil)
  • Concurrent use of organic nitrates (any form: glyceryl trinitrate, isosorbide mononitrate/dinitrate) - absolute contraindication
  • Recent or unstable cardiovascular disease
  • Myocardial infarction or stroke in last 3 months
  • Unstable angina
  • Uncontrolled arrhythmia or heart failure NYHA III-IV
  • Resting hypotension (SBP \< 90 mmHg) or uncontrolled hypertension (SBP \> 180 mmHg) per treating clinician
  • Known severe hepatic impairment or severe renal impairment on dialysis (if local clinician deems unsafe)
  • Known hypersensitivity to sildenafil or excipients
  • Concomitant use of potent CYP3A4 inhibitors (e.g., ritonavir) - unless clinician documents safe plan/dose adjustment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 21, 2026

Study Start

February 6, 2026

Primary Completion (Estimated)

February 5, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01