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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Fulvestrant
  Participants will receive fulvestrant 250 mg intramuscularly on Days 1 and 29, then monthly for 6 months.
• Препарат Anastrozole (ARIMIDEX™)
  Participants will receive anastrozole 1 mg orally once daily for 6 months.

Первичные конечные точки

• Composite Safety Event Rate [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Serum Estradiol Level [Срок оценки: Baseline to 6 months]
• Serum Testosterone Level [Срок оценки: Baseline to 6 months]
• Serum LH Level [Срок оценки: Baseline to 6 months]
• Serum FSH Level [Срок оценки: Baseline to 6 months]
• Hernia Size on Ultrasound [Срок оценки: Baseline to 6 months; baseline to 1 year]
• Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) Score [Срок оценки: Baseline to 6 months; baseline to 1 year]
• European Registry for Abdominal Wall Hernias Quality of Life (EuraHS-QoL) Score [Срок оценки: Baseline to 6 months; baseline to 1 year]
• Bone Mineral Density on DEXA [Срок оценки: Baseline to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Northwestern Memorial Hospital — Chicago

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 35439171

Идентификаторы

NCT: NCT07604272 · 00225501

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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