About this trial
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 criteria
Qualifiers
Male sex
Age ≥ 50 years at time of enrollment
Symptomatic unilateral inguinal hernia confirmed on physical examination
Hernia visible / confirmed on groin ultrasound
Disqualifiers
Scrotal hernia (any)
Bilateral inguinal hernia
Recurrent inguinal hernia (prior repair at same site)
Clinically significant renal dysfunction judged by investigator to increase study risk
Trial design
Treatments tested in this trial
- Fulvestrant
- Anastrazole