A clinical trial to study effectiveness and safety of Udenafil tablets in patients suffering from erectile dysfunction

Phase 3

Completed

Conditions: Male erectile dysfunction, unspecified,

Registration Number: CTRI/2010/091/001119

Lead Sponsor: Cadila Healthcare Ltd

Brief Summary: This study is a randomized, double blind, placebo controlled, multicentric study comparing the safety and efficacy of Udenafil 100 mg tablets and matching placebo given 30 minutes to 1 hour before anticipated sexual intercourse each for 8 weeks; in 120 patients with erectile dysfunction that will be conducted in five centers in India. The primary outcome measures will be the change in the Erectile function domain of IIEF questionnaire..

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Male

Target Recruitment: 120

Inclusion Criteria

1.Male patients of 18 to 60 years of age 2.Stable, monogamous heterosexual relationship 3.Established diagnosis of erectile dysfunction (ED) 4.Informed consent of the patient.

Exclusion Criteria

1.Total erectile failure or any other sexual disorder2.Hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie?s disease or penile trauma3.History of major psychiatric disorder4.History of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease5.History of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery6.Patients with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders7.History of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION)8.History of disorders that may cause priapism9.Any concomitant treatment which is not permissible10.Known hypersensitivity to PDE 5 inhibitors 11.Any other serious concurrent illness or malignancy12.Continuing history of alcohol and / or drug abuse13.Recent participation in another clinical trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in the Erectile function domain of IIEF questionnaire	Baseline, 4 & 8 Weeks

Secondary Outcome Measures

Name	Time	Method
(1)The change in the total score of IIEF questionnaire	(2)Patient?s global impression of change

Trial Locations

Locations (6): Angat Clinic, Surat
🇮🇳
Surat, GUJARAT, India
Centre for Male Infertility & Men's Health Clinic, Indore
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Indore, MADHYA PRADESH, India
Manasthali, Jaipur
🇮🇳
Jaipur, RAJASTHAN, India
Menz Health Clinic, Noida
🇮🇳
Nagar, UTTAR PRADESH, India
Samvedana Psychiatric & Sex Therapy Clinic, Ahmedabad
🇮🇳
Ahmadabad, GUJARAT, India
Suman Vinayaka Nursing Home, Mandya
🇮🇳
Mandya, KARNATAKA, India
Angat Clinic, Surat
🇮🇳Surat, GUJARAT, India
Dr. Mukul Choksi
Principal investigator
mukulchoksi@gmail.com