Reversing Inguinal Hernia Trial: Evaluating Hormones in Men

This study is looking at whether certain hormone-blocking medications can help reverse inguinal hernias (a bulge in the groin area) in men aged 50 and older. Participants will receive either fulvestrant (an injection) or anastrozole (an oral pill) for six months. The main goal is to check the safety of these treatments. Researchers will also look at how well the treatments are tolerated, changes in hormone levels, hernia size, and how participants feel. To join, you must be a man at least 50 years old with a symptomatic, non-recurrent inguinal hernia confirmed by ultrasound. The study plans to enroll 30 participants, but its current status is unclear.

Study design
This is a Phase 1, single-center study that will randomly assign 30 men to one of three treatment groups. Participants will receive either fulvestrant (250 mg or 500 mg) or anastrozole (5 mg).
What's involved
You would receive injections of fulvestrant on specific days for the first month, then monthly for six months, or take anastrozole daily for six months. You would also have required visits and laboratory assessments.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be measured at 6 months after starting treatment.

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NCT07604272

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

Recruiting
PHASE1Ages 50+InterventionalTreatment
Northwestern University
~30 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:FulvestrantAnastrozole (ARIMIDEX™)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Safety Event Rate
Measured over 6 months
Inguinal Hernia Unilateral
Inguinal Hernia Bilateral
Inguinal Hernia Without Obstruction or Gangrene
Inguinal Hernia, Without Mention of Obstruction or Gangrene
1 sites across 1 states
Illinois1

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Eligibility criteria

Inclusion

Male sex
Age ≥ 50 years at time of enrollment
Symptomatic unilateral inguinal hernia confirmed on physical examination
Hernia visible / confirmed on groin ultrasound
Non-recurrent inguinal hernia (primary hernia only)
Willing and able to provide written informed consent
Able and willing to comply with all protocol-required visits, laboratory assessments, imaging, and follow-up
Willing to use contraception and avoid fathering a child during study participation and for 12 months after last dose
Willing to be counseled regarding vitamin D and calcium supplementation Bone safety mitigation measure per PIND response.

Exclusion

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
Clinically significant hepatic dysfunction at baseline
Symptomatic benign prostatic hyperplasia (BPH) requiring active medical or procedural treatment
Clinically significant untreated prostate disease
Baseline osteoporosis (T-score ≤ -2.5 on DEXA at any site)
Recent fragility fracture (within prior 12 months or as judged by investigator)
Other clinically significant skeletal vulnerability judged to increase risk from estrogen suppression
Current use of androgen replacement therapy, exogenous estrogen, or other endocrine-active agents that would confound study interpretation
Prior or current use of aromatase inhibitor or selective estrogen receptor modulator / degrader within 6 months of enrollment
  • Composite Safety Event Rate6 months

    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.