Ascites complicating liver cirrhosis in males MedDRA version: 14.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 100000004871 MedDRA version: 14.1 Level: LLT Classification code 10021038 Term: Hyponatremia System Organ Class: 100000004861 MedDRA version: 14.1 Level: PT Classification code 10018800 Term: Gynaecomastia System Organ Class: 10038604 - Reproductive system and breast disorders MedDRA version: 14.1 Level: LLT Classification code 10003146 Term: A
Conditions
Interventions
Trade Name: Spironolakton 50 mg and 100 mg
Product Name: Spironolakton
Pharmaceutical Form: Tablet
Other descriptive name: SPIRONOLACTONE
Trade Name: Inspra 25 mg and 50 mg
Product Name: Inspra
Pharm
Sponsors
Region Skåne
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. A written informed consent to participate in the study is signed before any study-related procedures are performed. 2. Male subject aged > 18 years and 10 g/liter Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: 1. Therapy with spironolactone or eplerenone within 3 months prior to inclusion in the study (exception < 4 days of therapy with spironolactone immediately before inclusion in the study) 2. Prior/actual spontaneous bacterial peritonitis 3. Creatinine-clearance < 30 mL/min 4. Uncontrolled diabetes 5. Stroke within 6 months before inclusion in the study 6. Myocardial infarction within 6 months before inclusion in the study 7. Cardiac failure within 6 months before inclusion in the study 8. Known or suspected malignancies 9. Current therapy with drugs for erectile dysfunction 10. Current therapy with drugs for enlarged prostate 11. Current therapy with drugs interacting with spironolactone or eplerenone (Lithium, NSAID, ACE-inhibitors, AII-receptor blockers, trimethoprim, tricyclic antoidepressants, SSRI) 12. Current therapy with testosterone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if therapy with eplerenone is non-inferior to spironolactone (both in combination with furosemide) regarding efficacy for mobilisation of ascites in male patients with cirrhosis of the liver.;Secondary Objective: To evaluate if therapy with eplerenone - in doses which control ascites - is superior to spironolactone (both in combination with furosemide) regarding antiandrogenic side effects (gynaecomastia, erectile dysfunction,reduced sexual arousal/desire, sex-related quality of life). ;Primary end point(s): 1. Absence of clinically detectable ascites. 2. Reduced clinical ascites with stable body weight +/- 1 kg from study week 12.;Timepoint(s) of evaluation of this end point: 1. Study week 24 2. Study week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Absence or reduction of clinical ascites at week 12 2. Prevalence of refractory ascites at week 24 (defined according to international criteria – ref) 3. Alteration of breast tenderness > 1 degree from start of treatment to week 24 4. Alteration of gynaecomastia > 2 cm from start of treatment to week 24 5. Difference in score for sexual dysfunction from start of treatment to week 24 6. Difference in score for sexual dysfunction from start of treatment to week 24 7. Difference in score for sex-related QoL from start of treatment to week 24 8. Differences in serum hormoneconcentrations from start of treatment to week 24 ;Timepoint(s) of evaluation of this end point: 1. Study week 12 2 - 8. Study week 24 | — |
Countries
Sweden
Contacts
Public ContactGastrokliniken
Skåne University Hospital
Outcome results
None listed