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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07604272
Phase
PHASE1
Status
Not Yet Recruiting

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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, 15, and 29, then monthly for 6 months.
  • Anastrazole — DRUG
    Participants will receive anastrozole 5 mg orally once daily for 6 months.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 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, 15, and 29, then monthly for 6 months.
  • Experimental: Anastrozole 5 mg
    Participants will receive anastrozole 5 mg orally once daily for 6 months.

Primary Outcome Measure

Composite Safety Event Rate [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611
Nancy Ly, MD
[email protected]
3126956868

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By research site
Northwestern Memorial Hospital· Chicago, IL

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