Reversing InGuinal Hernia Trial RIGHT Trial The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males

What this Trial Is About

Researchers are evaluating anti-estrogen therapy in men aged 50 years and older who have symptomatic unilateral inguinal hernias. This Phase 1 safety and feasibility trial aims to assess the effects of treatments on hormone levels, hernia size, patient quality of life, bone density, and safety outcomes. The study is sponsored by Northwestern University and will compare two anti-estrogen drugs. Participants will be randomly assigned to one of two groups one group will receive Fulvestrant 250 mg by injection on Days 1 and 29, then monthly for 6 months, while the other group will take Anastrozole 1 mg orally once daily for 6 months. These treatments are being studied to see how they affect hernia characteristics and hormone changes over time. During the study, participants will have regular assessments including ultrasound imaging of the hernia, blood tests to measure hormone levels, bone density scans, and quality of life questionnaires. Researchers will monitor safety and tolerability throughout the 6-month treatment period and continue follow-up for up to one year. The main outcome measured is the composite safety event rate at 6 months.

Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males