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

Conditions

• Inguinal Hernia Bilateral
• Inguinal Hernia Unilateral
• Inguinal Hernia Without Obstruction or Gangrene
• Inguinal Hernia, Without Mention of Obstruction or Gangrene

Eligibility Criteria

Sex

MALE

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fulvestrant — DRUG
  Participants will receive fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.
• Anastrozole (ARIMIDEX™) — DRUG
  Participants will receive anastrozole 1 mg orally once daily for 6 months.

Study Details

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.

Key Dates

First listed

May 22, 2026

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fulvestrant 250 mg
  Participants will receive Fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.
• Experimental: Anastrozole 1 mg
  Participants will receive anastrozole 1 mg orally once daily for 6 months.

Primary Outcome Measure

Composite Safety Event Rate [ Time Frame: 6 months ]

Locations (1)

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