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NCT07604272 · ClinicalTrials.gov registry record · Phase 1
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
A Phase 1 study, sponsored by Northwestern University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT07604272: Recruiting Phase 1 study, sponsored by Northwestern University.
NCT07604272 is a Phase 1 study that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07604272, a Phase 1 study, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Fulvestrant
- DRUG Anastrazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-06 |
| Phase | Phase 1 |
What NCT07604272 shows while recruiting
NCT07604272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT07604272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07604272 about?
NCT07604272 is a clinical study titled "Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males". 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 intramus...
What is the current status of trial NCT07604272?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-07-01. Estimated completion is 2028-06.
What interventions are being tested in trial NCT07604272?
The interventions under investigation include: Fulvestrant (DRUG), Anastrazole (DRUG).
Who is sponsoring clinical trial NCT07604272?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07604272's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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