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

A randomized, double blind, placebo controlled, multicentric study to assess the efficacy and safety of Udenafil tablets in patients suffering from erectile dysfunction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/001119

Enrollment

120

Registered

2010-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Erectile dysfunction Health Condition 2: N529- Male erectile dysfunction, unspecified

Interventions

Intervention1: Udenafil 100 mg tablets: 30 minutes to 1 hour before anticipated sexual intercourse, for 8 weeks Control Intervention1: Matching Placebo tablets: 30 minutes to 1 hour before anticipated

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Total erectile failure or any other sexual disorder 2. Hypogonadism or anatomical deformity of the penis such as severe penile fibrosis or Peyronie?s disease or penile trauma 3. History of major psychiatric disorder 4. History of significant pathological cardiovascular conditions such as: congestive heart failure, life-threatening arrhythmia or ischemic heart disease 5. History of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery 6. Patients with hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders 7. History of retinitis pigmentosa, proliferative diabetic retinopathy or non-arteritic anterior ischemic optic neuropathy (NAION) 8. History of disorders that may cause priapism 9. Any concomitant treatment which is not permissible 10. Known hypersensitivity to PDE 5 inhibitors 11. Any other serious concurrent illness or malignancy 12. Continuing history of alcohol and / or drug abuse 13. Recent participation in another clinical trial

Design outcomes

Primary

Measure	Time frame
The change in the Erectile function domain of IIEF questionnaireTimepoint: Baseline, 4 & 8 Weeks	—

Secondary

Measure	Time frame
(1) The change in the total score of IIEF questionnaire (2) Patient?s global impression of change (3) Overall assessment of efficacy Timepoint: Baseline, 4 & 8 Weeks	—

Countries

India

Contacts

Public ContactDr Ravindra Mittal

Cadila Healthcare Ltd.

r.mittal@zyduscadila.com07926868926

Outcome results

None listed

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