Primary Care ERectile Function Outcome Registry for Men (PERFORM)

January 14, 2026 updated by: Nabiqasim Industries (Pvt) Ltd
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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult Male ED patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. If at any other PDE-5 inhibitor (sildenafil, tadalafil, vardenafil, avanafil)
  2. Concurrent use of organic nitrates (any form: glyceryl trinitrate, isosorbide mononitrate/dinitrate) - absolute contraindication

  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive data of frequency, severity of ED in Pakistan
Time Frame: Baseline
Prevalence
Baseline
Descriptive data [age, income (derivative of socio-economic class), rural/urban population and occupation]
Time Frame: baseline
Demographics
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age of diabetes in ED patients
Time Frame: baseline
Duration of diabetes in ED patients
baseline
Duration of ED
Time Frame: baseline
Disease duration
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabiqasim Industries (Pvt) Ltd

Collaborators

Pakistan Society of Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 6, 2026

Primary Completion (Estimated)

February 5, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NQ/AP/SLR/Reg-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Local sensitive data due to privacy concerns

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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