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Not yet recruiting NCT07356609

Primary Care ERectile Function Outcome Registry for Men

— Observational Erectile Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Erectile Dysfunction. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Descriptive data of frequency, severity of ED in Pakistan [Time frame: Baseline]
  • Descriptive data [age, income (derivative of socio-economic class), rural/urban population and occupation] [Time frame: baseline]
Secondary outcome measures (2)
  • Age of diabetes in ED patients [Time frame: baseline]
  • Duration of ED [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Adult male above 18 years of age
  • Married
  • Diabetic
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07356609 · NQ/AP/SLR/Reg-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗