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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Fulvestrant 250 mg |
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. |
|
Recruiting Locations
Chicago, Illinois 60611
More Details
- Status
- Recruiting
- Sponsor
- Northwestern University