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
Northwestern University
30 participants
Jul 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- 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 Criteria25
- 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
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Interventions
Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.
Participants will receive anastrozole 5 mg orally once daily for 6 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07604272