AzTrials
AzTrials

CirrhosisNCT03566914

Tadalafil for Erectile Dysfunction in Patients With Cirrhosis

A study testing Tadalafil 10 MG in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 21 to 60 years
Conditions the study is for
Cirrhosis
What is being tested?
Tadalafil 10 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteIndia
Study dates
30 Jun 2018to 28 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male patients, age from 21 years to 60 years ;
  • Child´s Grade A or B cirrhosis (CTP score up to 9) of any etiology;
  • A minimum 3-month history of mild-to-severe ED;
  • A stable monogamous relationship with a female partner and anticipate having same adult female sexual partner during the study.
  • 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.
  • Men with a history of hypertension, hypercholesterolemia and diabetes will be included.
Show all 9Show fewer
  • 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).
  • 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).
  • 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).

Who cannot join

  • 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.
  • 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.
  • 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.
  • 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.
  • Patients with history of hypersensitivity to the trial drugs or to drugs with a similar chemical structure,
  • Patients with Karnofsky performance status of below 70% were excluded
  • Patient with uncontrolled thyroid disorders.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Dr Rakesh Kumar Jagdish

    New Delhi, National Capital Territory of Delhi, 110070

Other trials in India

About this study

Official title: A Randomized Placebo Controlled Trial of Tadalafil for Erectile Dysfunction in Patients With Cirrhosis

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.

Conditions
Cirrhosis
Being tested
Tadalafil 10 MG, Placebo
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tadalafil 10 MGDrug

    Tadalafil 10 mg per oral once daily for 3 months

  • PlaceboOther

    TPlacebo tablet per oral once daily for 3 months

Study groups in NCT03566914
Study groupRoleWhat they receive
TadalafilExperimentalTadalafil 10 mg once daily per oral for 3 months
Receives: Drug: Tadalafil 10 MG
PlaceboPlacebo comparatorTablet placebo once daily per oral for 3 months
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3 Months

Secondary outcomes (9)

  1. Number of patients with erectile Dysfunction

    Measured: 1.5 years

  2. Side effects of tadalafil drug

    Measured: 3 months

  3. Reduction in HVPG (Hepatic Venous Pressure Gradient) ≥10 in both groups

    Measured: 3 Months

  4. Change in Sexual Encounter Profile (SEP) in both groups

    Measured: 3 Months

  5. Global Assessment Index in both groups

    Measured: 3 Months

  6. Improvement in q ADAMS in both groups

    Measured: 3 Months

  7. Improvement in PHQ 9 in both groups

    Measured: 3 Months

  8. Improvement in GAD 7 in both groups

    Measured: 3 Months

  9. Improvement in SF-36 in both groups

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2018
  2. Study start30 Jun 2018
  3. Primary completion28 Dec 2019
  4. Study completion28 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03566914
Sponsor's protocol ID
ILBS-Cirrhosis-16
Status last verified
Jul 2021
First submitted
12 Jun 2018
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 34775577

Questions about this trial

What is this clinical trial studying?

A study testing Tadalafil 10 MG in people with Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03566914, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in