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Clinical Trials/NCT07356609
NCT07356609Not yet recruitingNot Applicable

Primary Care ERectile Function Outcome Registry for Men

Nabiqasim Industries (Pvt) Ltd0 sites255 target enrollmentStarted: February 6, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
255

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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