Health Condition 1: null- Cirrhosis Health Condition 2: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Tadalafil: 10 mg once daily per oral for 3 months
Control Intervention1: Placebo: Once daily per oral for 3 months
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male patients, age from 21 years to 60 years ; 2. Child´s Grade A or B cirrhosis (CTP score up to 9) of any etiology; 3. A minimum 3-month history of mild-to-severe ED; 4. A stable monogamous relationship with a female partner and anticipate having same adult female sexual partner during the study. 5. Sexually active- They should also agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication; agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization. 6. Men with a history of hypertension, hypercholesterolemia and diabetes will be included. 7. Following beta-blocker therapy was allowed: Carvedilol (up to the max. dose of 25 mg) and propranolol (up to the max. dose of 160 mg). 8. Patients will be included if they were not on beta-blocker or on a stable dose of beta-blocker for at least last 6 weeks ( beta-blocker dose was not modified during the duration of the study). 9. Patients with history of endoscopically diagnosed large esophageal varices without previous bleeding will be included if they were on a stable dose of prophylactic beta blocker for at least last 6 weeks ( beta-blocker dose was not modified during the duration of the study) or on endoscopic band ligation sessions ( should have small esophageal varices at the time on enrollment in the study, and the last endoscopic band ligation session at least >1 week ago).
Exclusion criteria
Exclusion criteria: 1. Patients with overt hepatic encephalopathy; Child´s grade C cirrhosis; history of variceal bleeding within last 4 weeks [ patients were included if they bled >4 weeks ago and were on secondary prophylaxis with endoscopic band ligation( should have small esophageal varices at the time on enrollment in the study, and the last endoscopic band ligation session at least >1 week ago) and/or beta-blockers ; and hepatocellular carcinoma; acute decompensated state of cirrhosis like gastrointestinal bleed/increased jaundice, active infection, post TIPS patients, acute febrile illness excluded. 2. Patients with HbA1c >13.0% at the screening visit (visit 1, week â??4), a recent history of diabetic ketoacidosis (>= 2 episodes), or >= 3 episodes of hypoglycemia requiring assistance were excluded. However, men with microvascular complications, including retinopathy, were eligible. 3. Patients with history of angina during intercourse, unstable angina, or any other evidence of recently diagnosed coronary artery disease, poorly controlled blood pressure (systolic >170 or_ 100 or _ 4. Men who failed to achieve an erection after radical prostatectomy or pelvic surgery; those who had penile implants, clinically noteworthy penile deformities, or a history of psychiatric disorders, stroke or spinal-cord trauma within 6 months of study onset; those who were receiving nitrates, antiandrogens, antidepressant, anticonvulsants, other hypnotics or cancer chemotherapy; and patients with active alcohol intake or intake within 1 month of enrollment, active substance abuse or intake within 1 month of enrollment also excluded. 5. Patients with history of hypersensitivity to the trial drugs or to drugs with a similar chemical structure, 6. Patients with Karnofsky performance status of below 70% were excluded 7. Patient with uncontrolled thyroid disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response of tadalafil 10 mg vs placebo in erectile dysfunction in patients with child A and B cirrhosisTimepoint: 3 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of tadalfil vs placebo in a subgroup of patients with HVPG more than 10 mm Hg.Timepoint: 3 Months;Effect on HVPG among patients with HVPG more than 10 at end of 3 monthTimepoint: 3 Months;Improvement in erectile function across other domains: IIEF erectile function domain, erection vaginal penetration rates (SEP-Q2), and successful intercourse rates (SEP-Q3) at end of 3 month.Timepoint: 3 Months;Increase more than five points in erectile function domain score at end of 3 monthsTimepoint: 3 Months;side effects of the tadalafil drugTimepoint: 3 Months | — |
Countries
India
Contacts
Public ContactDr Rakesh Kumar Jagdish
Institute of Liver and Biliary Sciences
Outcome results
None listed