Reversing InGuinal Hernia Trial (RIGHT Trial): The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
This is a prospective, single-center, two-arm Phase 1 safety and feasibility trial evaluating anti-estrogen therapy in men age 50 years and older with symptomatic unilateral inguinal hernias. Participants will be randomized to receive Fulvestrant 250 mg intramuscularly or anastrozole 1 mg orally for 6 months. The study will evaluate safety, tolerability, feasibility, hormone changes, hernia size, patient-reported outcomes, bone density, and imaging-based hernia classification.
• Male sex
• Age ≥ 50 years at time of enrollment
• Symptomatic unilateral inguinal hernia confirmed on physical examination
• Hernia visible / confirmed on groin ultrasound
• Non-recurrent inguinal hernia (primary hernia only)
• Willing and able to provide written informed consent
• Able and willing to comply with all protocol-required visits, laboratory assessments, imaging, and follow-up
• Willing to use contraception and avoid fathering a child during study participation and for 12 months after last dose
• Willing to be counseled regarding vitamin D and calcium supplementation Bone safety mitigation measure per PIND response.