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NCT Number: NCT07356609

Primary Care ERectile Function Outcome Registry for Men

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Descriptive data of frequency, severity of ED in Pakistan

    Time frame: Baseline

    Prevalence

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

    Time frame: baseline

    Demographics

Secondary outcomes

  1. Age of diabetes in ED patients

    Time frame: baseline

    Duration of diabetes in ED patients

  2. Duration of ED

    Time frame: baseline

    Disease duration

Study contacts

Contact information is provided by the study sponsor or research team.

Hussain Abidi

CONTACT

[email protected]

+923322583236

Sponsors and collaborators

Lead sponsor

Nabiqasim Industries (Pvt) Ltd

Industry

Collaborators

  • Pakistan Society of Internal Medicine

Registry information

Acronym: PERFORM

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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