Menopause is a Critical Factor in Determining Failure of Antiviral Therapy in Women With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Menopause represents a critical period in a woman's life as the hormonal changes and the failing ovarian function not only determine relevant modifications in the reproductive function but also in many other conditions and organs that apparently are scarcely linked with hormones. The PI's centre has among its main goals the treatment of chronic liver disease; in the last years, a increasing interest in gender-related issues has grown.

Goal of this study is to verify the impact of menopause on response to antiviral therapy for CHC and in determining more severe fibrosis in comparison with age-matched men. To achieve this goal a database of all the PEG IFN/Ribavirin patients treated in the GI Unit of the University of Modena and Reggio Emilia in the last 7 years will be set up. Demographic, clinical and biochemical data as well data regarding the reproductive history, time, type, length of estrogen deprivation and of hormone-replacement therapy will be collected.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Facchinetti Fabio
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Antiviral Agents; Ribavirin

Criteria

Inclusion Criteria:

• All women treated for HCV chronic hepatitis, at the Unit Gastroenterology, University of Modena and Reggio Emilia, in the last 7 years.

• Control group is a cohort matched for age (ratio 1:1) selected from a group of 558 men with chronic HCV treated in the same period

Exclusion Criteria:

• No exclusion criteria aret pre-defined as the study includes all patients who were treated for chronic HCV hepatitis; exclusion was made upstream of the constitution of this cohort.