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A clinical study to assess role of oral avanafil and intracavernosal injection of alprostadil in evaluation of patients with low Erection Hardness Score.

A prospective study to assess the role of oral Avanafil and intracavernosal injection of Alprostadil in evaluating patients with low Erection Hardness Score. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056227
Enrollment
164
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N529- Male erectile dysfunction, unspecified

Interventions

Intervention1: Tablet Avanafil 100mg: Patients presenting with Erecttile Dysfunction for their evaluation will be given 100mg Oral Avanafil and Erection Hardness Score will be evaluated after 15-20 mi

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients presenting to our OPD with ED of more than 1 month, Irrespective of marital status, comorbidities shall be further evaluated with International Index of Erectile Function (IIEF-5) questionnaire and for all relevant medical and sexual history. Only patients with EHS 1 or 2 based on history will be included in the study

Exclusion criteria

Exclusion criteria: 1. Tried PDE5 inhibitors in the past and had discontinued either due to significant side-effects, or had known hypersensitivity to PDE5 inhibitors; 2. Patients with history of primary hypoactive sexual desire, hypogonadism(serum total testosterone levels less than 300ng/dL) 3. spinal cord injury, 4. pelvic surgery and radical prostatectomy; 5. History of or predisposition to priapism; presence of penile anatomical abnormalities; and use of penile implants. 6. Penile surgery other than circumcision. 7. EHS 0 or EHS 3,4.

Design outcomes

Secondary

MeasureTime frame
Side effectsTimepoint: Upto 24-48 hours

Primary

MeasureTime frame
Improvement in Erection Hardness Score from BaselineTimepoint: 30 minutes

Countries

India

Contacts

Public ContactDr Manish Kumar

Sri Narayani Hospital and Research Centre

manishkumar.ms08@gmail.com9790588322

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026