Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males (NCT07604272) | Clinical Trial Compass
RecruitingPhase 1
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
United States30 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 increa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.