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Not yet recruitingNCT07356609PERFORMUpdated Jan 21, 2026

Primary Care ERectile Function Outcome Registry for Men

An observational study in Erectile Dysfunction, sponsored by Nabiqasim Industries (Pvt) Ltd. Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Nabiqasim Industries (Pvt) Ltd · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
255
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Erectile dysfunction
  • male reproductive health
  • male sexual health
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult Male ED patients

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
255 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
05

What researchers measure

Primary outcomes

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

    Prevalence

    Time frame: Baseline

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

    Demographics

    Time frame: baseline

Secondary outcomes

  1. Age of diabetes in ED patients

    Duration of diabetes in ED patients

    Time frame: baseline

  2. Duration of ED

    Disease duration

    Time frame: baseline

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Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided — Local sensitive data due to privacy concerns

08

Registry details

Key details

Study ID
NCT07356609
Lead sponsor
Nabiqasim Industries (Pvt) Ltd
Collaborators
Pakistan Society of Internal Medicine
Responsible party
Sponsor
First posted
Jan 21, 2026
Start date
Feb 6, 2026 (estimated)
Primary completion
Feb 5, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Jan 21, 2026

Study contacts

Hussain Abidi
Contact
hussain.baqar@nabiqasim.com
+923322583236

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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