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

Purpose

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

Eligibility

Eligible Ages
Over 50 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Fulvestrant 250 mg
Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.
  • Drug: Fulvestrant
    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.
  • Drug: Anastrazole
    Participants will receive anastrozole 5 mg orally once daily for 6 months.

Recruiting Locations

Northwestern Memorial Hospital
Chicago, Illinois 60611
Contact:
Nancy Ly, MD
3126956868
nancy.ly@nm.org

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact