NCT07604272招募中1 期
Reversing InGuinal Hernia Trial (RIGHT Trial): The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •■ 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
研究组 & 干预措施
Fulvestrant 250 mg
Experimental
Participants will receive fulvestrant 250 mg intramuscularly on Days 1, 15, and 29, then monthly for 6 months.
干预措施: Fulvestrant (Drug)
研究者
Megan Melland-Smith
Co-Investigator
Northwestern University
研究点 (1)
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