Testosterone Implants and the Incidence of Breast Cancer RETROSPECTIVE CHART REVIEW
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,268
- 主要终点
- Incidence of invasive breast cancer
研究概览
简要总结
This current chart review study was designed to investigate the incidence of breast cancer in women treated with subcutaneous testosterone therapy for symptoms of hormone deficiency.
详细描述
A prior ten-year prospective, observational, study was initially approved in March of 2008 by the IRB board through the Atrium Medical Center, Premier Health Partners in Middletown, Ohio 45005 and registered through the Office for Human Research Protections (OHRP). Expedited approval continued annually through 2013 at which time the IRB board was closed. All participants signed a study consent and HIPPA consent. Recruitment closed in 2013. The original protocol was designed to investigate the incidence of breast cancer in women presenting with symptoms of hormone deficiency treated with subcutaneous testosterone implants or, testosterone combined with the aromatase inhibitor anastrozole implants. A computer program was specifically designed to track and follow patients prospectively and all patients continued to be followed through 2018.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 24 Years 至 92 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients treated between March 2008 - March 2013
- •Women who received at least two testosterone pellet insertion procedures
- •Women previously accrued to the prospective cohort study
排除标准
- •Pre-existing breast cancer
- •Women who received a single testosterone pellet insertion
结局指标
主要结局
Incidence of invasive breast cancer
时间窗: 10-year results
The incidence of invasive breast cancer in women treated with testosterone therapy
次要结局
- Incidence of ductal carcinoma in situ(10-year results)
研究者
Rebecca L. Glaser, M.D.
Physician, PI
Millennium Wellness LLC