Eplerenone versus spironolactone for treatment of accumulated fluid in the peritoneal cavity due to cirrhosis of the liver in males. A Swedish study of effect and hormonal side effects - performed at Swedish university hospitals

• Conditions: Ascites complicating liver cirrhosis in males; MedDRA version: 14.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 100000004871; MedDRA version: 14.1Level: LLTClassification code 10021038Term: HyponatremiaSystem Organ Class: 100000004861; MedDRA version: 14.1Level: PTClassification code 10018800Term: GynaecomastiaSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 14.1Level: LLTClassification code 10003146Term: Arterial blood pressure decreasedSystem Organ Class: 100000004848; MedDRA version: 14.1Level: LLTClassification code 10040409Term: Serum testosteroneSystem Organ Class: 100000004848; MedDRA version: 15.1Level: LLTClassification code 10025522Term: Male sexual dysfunction NECSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 14.1Level: LLTClassification code 10025503Term: Male erectile disorderSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 14.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871; MedDRA version: 14.1Level: LLTClassification code 10023422Term: Kidney function abnormalSystem Organ Class: 100000004857

• Registration Number: EUCTR2011-001264-22-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-08
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

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 < 70 years
3. A definitive diagnosis of cirrhosis of the liver with clinically demonstrable ascites
4. A difference between plasma albumin concentration and ascites albumin concentration of > 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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br>;Primary end point(s): 1. Absence of clinically detectable ascites.<br>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<br>2. Study week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Absence or reduction of clinical ascites at week 12<br>2. Prevalence of refractory ascites at week 24 (defined according to international criteria – ref)<br>3. Alteration of breast tenderness > 1 degree from start of treatment to week 24<br>4. Alteration of gynaecomastia > 2 cm from start of treatment to week 24<br>5. Difference in score for sexual dysfunction from start of treatment to week 24<br>6. Difference in score for sexual dysfunction from start of treatment to week 24<br>7. Difference in score for sex-related QoL from start of treatment to week 24<br>8. Differences in serum hormoneconcentrations from start of treatment to week 24<br>;Timepoint(s) of evaluation of this end point: 1. Study week 12<br>2 - 8. Study week 24