A clinical study to assess role of oral avanafil and intracavernosal injection of alprostadil in evaluation of patients with low Erection Hardness Score.
- Conditions
- Health Condition 1: N529- Male erectile dysfunction, unspecified
- Registration Number
- CTRI/2023/08/056227
- Lead Sponsor
- I
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in Erection Hardness Score from BaselineTimepoint: 30 minutes
- Secondary Outcome Measures
Name Time Method Side effectsTimepoint: Upto 24-48 hours