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

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

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.

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