Tadalafil for Erectile Dysfunction in Patients With Cirrhosis

Summary

This study will be conducted into two parts 1) Screening of 400 cases of cirrhosis (Child A,child B and child c) for the prevalence and risk factors of erectile dysfunction in cirrhosis.2) The part 2 is RCT as follows where 70 cases in each arm will be taken wuth child A and child B cirrhosis for the effect of treatment on erectile dysfunction (Tadalafil vs Placebo). After getting informed consent. Clinical, anthropometric and biochemical assessment will be done by candidate, co-supervisors and supervisor. Screening and selection criteria by using various questionnaire like Karnofsky Performance Score (KPS) , IIEF Questionnaire , ADAMS Questionnaire, Generalized Anxiety Disorder 7 (GAD-7) questionnaire, Patient Health Questionnaire (PHQ-9 for depression ; and SF-36 questionnaire). The informed consent will be obtained from the participants in the study. Patients-ED IIEF\<25 will be included as per inclusion and exclusion criteria. Tadalfil regimen: 10 mg daily at any time before anticipated sexual activity on days with anticipated sexual activity On days with no anticipated sexual activity: 10 mg daily at night after meals. Follow-up1 week, 2weeks, 4weeks, 12 weeks with history, clinical examination and laboratory test.

Timeline

Start

2018-06-30

Primary completion

2019-12-28

Completion

2019-12-28

Publications

• Jagdish RK, Kamaal A, Shasthry SM, Benjamin J, Maiwall R, Jindal A, Choudhary A, Rajan V, Arora V, Bhardwaj A, Kumar G, Kumar M, Sarin SK. Tadalafil improves erectile dysfunction and quality of life in men with cirrhosis: a randomized double blind placebo controlled trial. Hepatol Int. 2023 Apr;17(2):434-451. doi: 10.1007/s12072-021-10264-w. Epub 2021 Nov 14.

Drugs

Indications