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Inguinal Hernia UnilateralPhase 1RIGHTNCT07604272

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

A Phase 1 study testing Fulvestrant and Anastrozole (ARIMIDEX™) in people with Inguinal Hernia Unilateral and Inguinal Hernia Bilateral, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older, men only
What is being tested?
Fulvestrant and Anastrozole (ARIMIDEX™)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
2 Oct 2026to Jul 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Nancy Ly, MD, 3126956868, nancy.ly@nm.org

    Recruiting

Other trials in United States

About this study

Official title: Reversing InGuinal Hernia Trial (RIGHT Trial): The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males

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.

Being tested
Fulvestrant, Anastrozole (ARIMIDEX™)
Keywords
inguinal hernia, hernia, fulvestrant, anti-estrogen therapy, aromatase inhibitor, estrogen receptor, ESR1, male inguinal hernia, hormonal therapy, fibrosis, hernia prevention, hernia regression, anastrozole
Medical subject headings
Gangrene, Hernia, Inguinal, Hernia, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

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

  • Anastrozole (ARIMIDEX™)Drug

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

Study groups in NCT07604272
Study groupRoleWhat they receive
Fulvestrant 250 mgExperimentalParticipants will receive Fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.
Receives: Drug: Fulvestrant
Anastrozole 1 mgExperimentalParticipants will receive anastrozole 1 mg orally once daily for 6 months.
Receives: Drug: Anastrozole (ARIMIDEX™)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (8)

  1. Serum Estradiol Level

    Change in Serum Estradiol Level

    Measured: Baseline to 6 months

  2. Serum Testosterone Level

    Change in Serum Testosterone Level

    Measured: Baseline to 6 months

  3. Serum LH Level

    Change in Serum LH Level

    Measured: Baseline to 6 months

  4. Serum FSH Level

    Change in Serum FSH Level

    Measured: Baseline to 6 months

  5. Hernia Size on Ultrasound

    Change in Hernia Size on Ultrasound

    Measured: 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.

    Measured: 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.

    Measured: Baseline to 6 months; baseline to 1 year

  8. Bone Mineral Density on DEXA

    Change in Bone Mineral Density on DEXA

    Measured: Baseline to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start2 Oct 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07604272
Sponsor's protocol ID
00225501
Acronym
RIGHT
Status last verified
Oct 2026
First submitted
18 May 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared outside the study team. Aggregate study results may be disseminated through presentations and publications.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fulvestrant and Anastrozole (ARIMIDEX™) in people with Inguinal Hernia Unilateral and Inguinal Hernia Bilateral, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Safety Event Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07604272, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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