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

ConditionsInguinal Hernia UnilateralInguinal Hernia BilateralInguinal Hernia Without Obstruction or GangreneInguinal Hernia, Without Mention of Obstruction or Gangrene
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age50+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Fulvestrant 250 mgExperimental treatment 1 intervention
Group B: Anastrozole 1 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Composite Safety Event Rate

Proportion of participants experiencing a composite safety event, defined as hernia-related complications including incarceration, strangulation, or emergent surgery; drug-related toxicity Grade 2 or higher by CTCAE v5.0; or procedure/treatment-related events Clavien-Dindo Grade III or higher.

Time frame
6 months

Secondary outcomes

1

Serum Estradiol Level

Change in Serum Estradiol Level

Time frame
Baseline to 6 months
2

Serum Testosterone Level

Change in Serum Testosterone Level

Time frame
Baseline to 6 months
3

Serum LH Level

Change in Serum LH Level

Time frame
Baseline to 6 months
4

Serum FSH Level

Change in Serum FSH Level

Time frame
Baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

Source ClinicalTrials.gov
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