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Tadalafil for Erectile Dysfunction in Patients With Cirrhosis

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ClinicalTrials.gov Identifier: NCT03566914
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:

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 as below .


Condition or disease Intervention/treatment Phase
Cirrhosis Drug: Tadalafil 10 MG Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Trial of Tadalafil for Erectile Dysfunction in Patients With Cirrhosis
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
Experimental: Tadalafil
Tadalafil 10 mg once daily per oral for 3 months
Drug: Tadalafil 10 MG
Tadalafil 10 mg per oral once daily for 3 months

Placebo Comparator: Placebo
Tablet placebo once daily per oral for 3 months
Other: Placebo
TPlacebo tablet per oral once daily for 3 months




Primary Outcome Measures :
  1. Proportions of patients achieving more than a five-point gain from baseline to end point in the erectile function domain of the IIEF ( International Index of Erectile Function). [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. Number of patients with erectile Dysfunction [ Time Frame: 1.5 years ]
  2. Side effects of tadalafil drug [ Time Frame: 3 months ]
  3. Reduction in HVPG (Hepatic Venous Pressure Gradient) ≥10 in both groups [ Time Frame: 3 Months ]
  4. Change in Sexual Encounter Profile (SEP) in both groups [ Time Frame: 3 Months ]
  5. Global Assessment Index in both groups [ Time Frame: 3 Months ]
  6. Improvement in q ADAMS in both groups [ Time Frame: 3 Months ]
  7. Improvement in PHQ 9 in both groups [ Time Frame: 3 Months ]
  8. Improvement in GAD 7 in both groups [ Time Frame: 3 Months ]
  9. Improvement in SF-36 in both groups [ Time Frame: 3 Months ]


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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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 -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_<90mm Hg or diastolic _>100 or _<50 mmHg) or orthostatic hypotension, arrhythmia, uncontrolled congestive heart failure, renal or respiratory failure, and anemia were also excluded.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566914


Contacts
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Contact: Rakesh Kumar Jagdish, MD 01146300000 rakeshkumarilbs@gmail.com

Locations
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India
Dr Rakesh Kumar Jagdish Recruiting
New Delhi, Delhi, India, 110070
Contact: Rakesh Kumar Jagdish, MD    01146300000    dr.rkj.kapil@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03566914     History of Changes
Other Study ID Numbers: ILBS-Cirrhosis-16
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Erectile Dysfunction
Pathologic Processes
Liver Diseases
Digestive System Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents