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

NCT07604272 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Fulvestrant

Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.

DRUG

Fulvestrant

Participants will receive fulvestrant 500 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.

DRUG

Letrozole

Participants will receive letrozole 5 mg orally once daily for 6 months.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604272 on ClinicalTrials.gov