See if anti-estrogen therapy can help men with a unilateral inguinal hernia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized Phase 1 study in men aged 50+ with a primary, symptomatic unilateral inguinal hernia. Participants will be assigned to receive either fulvestrant injections or anastrozole tablets for six months, with safety, tolerability, hormone changes, hernia size, and patient-reported outcomes tracked. The study also monitors bone density and imaging-based classification of the hernia to assess potential effects and feasibility of the approach. Primary goals are safety and feasibility rather than definitive efficacy. Results may inform whether anti-estrogen therapy could alter hernia biology or management in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

Hernia Characteristics

* Scrotal hernia (any)
* Bilateral inguinal hernia
* Recurrent inguinal hernia (prior repair at same site)

Renal \& Hepatic

* Clinically significant renal dysfunction judged by investigator to increase study risk
* Clinically significant hepatic dysfunction at baseline

Hematologic

■ Clinically significant baseline hematologic abnormality (including elevated hematocrit or polycythemia)

Urologic / Prostate

* Symptomatic benign prostatic hyperplasia (BPH) requiring active medical or procedural treatment
* Clinically significant untreated prostate disease

Skeletal / Bone

* 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

Immunosuppression ■ Active immunosuppression (e.g., systemic corticosteroids, biologic agents, post-transplant regimens)

Psychiatric

■ Unstable or uncontrolled psychiatric illness that, in the investigator's judgment, would interfere with safe study participation

Reproductive / Fertility ■ Actively pursuing fertility or planning conception during study participation

Prior / Concomitant Therapy

* 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

General

■ Any other clinically significant medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would place the participant at unacceptable risk or compromise study integrity

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.