Could hormone drugs replace hernia surgery?
NCT ID NCT07604272
First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 5 times
Summary
This early-stage trial tests whether anti-estrogen drugs (fulvestrant or anastrozole) can shrink inguinal hernias in men aged 50 and older. Thirty men with a symptomatic hernia will receive one of the drugs for 6 months. The main goal is to check safety and see if the hernia gets smaller on ultrasound.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fulvestrant and anastrozole (anti-estrogen drugs)
- What this could lead to
- If successful, this could point toward a non-surgical way to treat inguinal hernias in older men.
- What could go wrong
- This is a very early Phase 1 trial with only 30 men, so it may not show any benefit. The drugs can cause side effects like bone loss or hormone changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern Memorial Hospital
RECRUITINGChicago, Illinois, 60611, United States
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