Clinical study on subjects with impotence

Phase 2

• Conditions: Health Condition 1: N529- Male erectile dysfunction, unspecified

• Registration Number: CTRI/2023/10/059317
• Lead Sponsor: Emil Pharmaceutical Industries Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Healthy Subjects who have scored 22 to 25 on the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) at screening.

2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study

Exclusion Criteria

1.Subjects with known major illnesses and sexual dysfunction due to anatomical, surgical, or pharmacological causes

2. History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator.

3. Presence of any drug or therapy that may have relation with ED and sexual dysfunction

4. Subjects with total erectile failure

5. Subjects with known hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie disease or penile trauma

6. Subjects with history of disorders that may cause priapism

7. Subjects who are taking any medication for psychiatric disorder

8. Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery

9. Subjects with hypotension or hypertension, diabetes, hepatic impairment, renal impairment or hematological disorders

10. Subjects with significant abnormal laboratory parameters

11. Known cases of varicocele, hydrocele, HIV, AIDS, Hepatitis C and B, Cancer and major debilitating diseases

12. Subject having known hypersensitivity to any ingredient of the study products.

Study & Design

• Study Type: Interventional
• Study Design: Not specified