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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age50+
SponsorNorthwestern University

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

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators