Reversing InGuinal Hernia Trial (RIGHT Trial): The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
Northwestern University
Summary
This is a prospective, single-center, three-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, fulvestrant 500 mg intramuscularly, or letrozole 5 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.
Eligibility
- Age range
- 50+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 supplem…
Interventions
- DrugFulvestrant
Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.
- DrugAnastrazole
Participants will receive anastrozole 5 mg orally once daily for 6 months.
Location
- Northwestern Memorial HospitalChicago, Illinois