Reversing Inguinal Hernia Trial: Evaluating Hormones in Men
This study is looking at whether certain hormone-blocking medications can help reverse inguinal hernias (a bulge in the groin area) in men aged 50 and older. Participants will receive either fulvestrant (an injection) or anastrozole (an oral pill) for six months. The main goal is to check the safety of these treatments. Researchers will also look at how well the treatments are tolerated, changes in hormone levels, hernia size, and how participants feel. To join, you must be a man at least 50 years old with a symptomatic, non-recurrent inguinal hernia confirmed by ultrasound. The study plans to enroll 30 participants, but its current status is unclear.
- Study design
- This is a Phase 1, single-center study that will randomly assign 30 men to one of three treatment groups. Participants will receive either fulvestrant (250 mg or 500 mg) or anastrozole (5 mg).
- What's involved
- You would receive injections of fulvestrant on specific days for the first month, then monthly for six months, or take anastrozole daily for six months. You would also have required visits and laboratory assessments.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be measured at 6 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Composite Safety Event Rate6 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.