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 2026-10-06.
Sponsored by Northwestern University · Phase 1, Interventional, and Treatment
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.
23 studies on the registry are indexed under Gangrene; 3 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 15 interventional studies indexed under Gangrene.
Browse Gangrene studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hernia Characteristics
Renal \& Hepatic
Hematologic
■ Clinically significant baseline hematologic abnormality (including elevated hematocrit or polycythemia)
Urologic / Prostate
Skeletal / Bone
■ Active immunosuppression (e.g., systemic , 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
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.
Drug: Fulvestrant
Participants will receive anastrozole 1 mg orally once daily for 6 months.
Drug: Anastrozole (ARIMIDEX™)
Participants will receive fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.
Participants will receive anastrozole 1 mg orally once daily for 6 months.
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
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.
Started Oct 2026 (actual). Primary completion is estimated for Jul 2028, 21 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Oct 2026, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Fulvestrant · Anastrozole