NCT07604272 · Northwestern University
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
(RIGHT)
What this study is about
This is a forward-looking, single-center, three-treatment group$1 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 randomly assigned to receive fulvestrant 250 mg intramuscularly, fulvestrant 500 mg intramuscularly, or letrozole 5 mg taken by mouth for 6 months.
View original scientific description
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.
Interventions
DRUG
Fulvestrant
Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.
DRUG
Anastrazole
Participants will receive anastrozole 5 mg orally once daily for 6 months.
Primary outcome measures
Composite Safety Event Rate
Time frame: 6 months
Proportion of participants experiencing a composite safety event, defined as hernia-related complications including incarceration, strangulation, or emergent surgery; drug-related toxicity Grade 2 or higher by CTCAE v5.0; or procedure/treatment-related events Clavien-Dindo Grade III or higher.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 26, 2026 · Source of record for eligibility and locations