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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.
Participants will receive anastrozole 5 mg orally once daily for 6 months.
Northwestern Memorial Hospital
Chicago, Illinois, United States
Composite Safety Event Rate
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.
Time frame: 6 months
Serum Estradiol Level
Change in Serum Estradiol Level
Time frame: Baseline to 6 months
Serum Testosterone Level
Change in Serum Testosterone Level
Time frame: Baseline to 6 months
Serum LH Level
Change in Serum LH Level
Time frame: Baseline to 6 months
Serum FSH Level
Change in Serum FSH Level
Time frame: Baseline to 6 months
Hernia Size on Ultrasound
Change in Hernia Size on Ultrasound
Time frame: Baseline to 6 months; baseline to 1 year
Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) Score
The EQ-5D-5L is a standardized quality-of-life instrument assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Index scores range from 0-5, with higher scores indicating worse health-related quality of life.
Time frame: Baseline to 6 months; baseline to 1 year
European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) Score
The EuraHS-QoL questionnaire assesses pain, activity restriction, and cosmetic discomfort related to abdominal wall hernias. Scores range from 0 to 90, with higher scores indicating worse hernia-related quality of life and symptom burden.
Time frame: Baseline to 6 months; baseline to 1 year
Bone Mineral Density on DEXA
Change in Bone Mineral Density on DEXA
Time frame: Baseline to 1 year
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