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RecruitingNCT07604272RIGHTUpdated Aug 3, 2026

Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males

A Phase 1 interventional study of Fulvestrant and Anastrozole (ARIMIDEX™) in Inguinal Hernia Unilateral, Inguinal Hernia Bilateral and Inguinal Hernia Without Obstruction or Gangrene, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Northwestern University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study summary

This is a prospective, single-center, two-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 or anastrozole 1 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.

02

Conditions studied

  • Inguinal Hernia Unilateral
  • Inguinal Hernia Bilateral
  • Inguinal Hernia Without Obstruction or Gangrene
  • Inguinal Hernia, Without Mention of Obstruction or Gangrene

Keywords

  • inguinal hernia
  • hernia
  • fulvestrant
  • anti-estrogen therapy
  • aromatase inhibitor
  • estrogen receptor
  • ESR1
  • male inguinal hernia
  • hormonal therapy
  • fibrosis
  • hernia prevention
  • hernia regression
  • anastrozole
03

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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

04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Fulvestrant 250 mg

    Participants will receive Fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.

    Drug: Fulvestrant

  • Experimental
    Anastrozole 1 mg

    Participants will receive anastrozole 1 mg orally once daily for 6 months.

    Drug: Anastrozole (ARIMIDEX™)

Interventions

  • DrugFulvestrant

    Participants will receive fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.

  • DrugAnastrozole (ARIMIDEX™)

    Participants will receive anastrozole 1 mg orally once daily for 6 months.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Serum Estradiol Level

    Change in Serum Estradiol Level

    Time frame: Baseline to 6 months

  2. Serum Testosterone Level

    Change in Serum Testosterone Level

    Time frame: Baseline to 6 months

  3. Serum LH Level

    Change in Serum LH Level

    Time frame: Baseline to 6 months

  4. Serum FSH Level

    Change in Serum FSH Level

    Time frame: Baseline to 6 months

  5. Hernia Size on Ultrasound

    Change in Hernia Size on Ultrasound

    Time frame: Baseline to 6 months; baseline to 1 year

  6. 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

  7. 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

  8. Bone Mineral Density on DEXA

    Change in Bone Mineral Density on DEXA

    Time frame: Baseline to 1 year

06

Study locations

1 of 1 sites recruiting
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
    Recruiting
07

References and documents

Publications

  • Potluri T, You T, Yin P, Coon J 5th, Stulberg JJ, Dai Y, Escobar DJ, Lieber RL, Zhao H, Bulun SE. Estrogen receptor-alpha ablation reverses muscle fibrosis and inguinal hernias. J Clin Invest. 2025 Feb 4;135(6):e179137. doi: 10.1172/JCI179137. PubMed 39903526 ↗
  • Zhao H, Zhou L, Li L, Coon V J, Chatterton RT, Brooks DC, Jiang E, Liu L, Xu X, Dong Z, DeMayo FJ, Stulberg JJ, Tourtellotte WG, Bulun SE. Shift from androgen to estrogen action causes abdominal muscle fibrosis, atrophy, and inguinal hernia in a transgenic male mouse model. Proc Natl Acad Sci U S A. 2018 Oct 30;115(44):E10427-E10436. doi: 10.1073/pnas.1807765115. Epub 2018 Oct 16. PubMed 30327348 ↗
  • Matthews RD, Neumayer L. Inguinal hernia in the 21st century: an evidence-based review. Curr Probl Surg. 2008 Apr;45(4):261-312. doi: 10.1067/j.cpsurg.2008.01.002. No abstract available. PubMed 18358264 ↗
  • HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12. PubMed 29330835 ↗
  • Potluri T, Taylor MJ, Stulberg JJ, Lieber RL, Zhao H, Bulun SE. An estrogen-sensitive fibroblast population drives abdominal muscle fibrosis in an inguinal hernia mouse model. JCI Insight. 2022 Apr 19;7(9):e152011. doi: 10.1172/jci.insight.152011. PubMed 35439171 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared outside the study team. Aggregate study results may be disseminated through presentations and publications.

08

Registry details

Key details

Study ID
NCT07604272
Lead sponsor
Northwestern University
Responsible party
Megan Melland-Smith (Co-Investigator, Northwestern University) — Principal investigator
First posted
May 22, 2026
Start date
Jul 31, 2026
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Aug 3, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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