BridgeMD
New treatment option for Inguinal Hernia Unilateral
Official title Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
ClinicalTrials.gov ID: NCT07604272
What this study is testing
What is Fulvestrant?
Fulvestrant is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for inguinal hernia unilateral.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, men only
You may be able to join if
- 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)
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.