Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Management of Atypical Endometrial Hyperplasia: A Non-Inferiority Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Histologic Response Scoring of Biopsy Specimens
研究概览
简要总结
The purpose of this research study is to compare the uterus tissue of women who receive an intrauterine system to treat their endometrial hyperplasia with the uterine tissue of women who receive megestrol acetate to treat their hyperplasia. While both methods are commonly used in practice, investigators would like to see what effects each treatment has on uterine tissue.
详细描述
Primary Objective: To determine if Levonorgestrel-releasing intrauterine system is of equal efficacy to the standard systemic progestin therapy (megestrol acetate) based on endometrial sampling at 6 months after randomization. Non-inferiority analysis.
Secondary Objective(s):
- To determine the safety of each treatment modality.
- Determine the feasibility of transvaginal ultrasound to predict treatment response.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Complex atypical endometrial hyperplasia only. Confirmed by pathology report.
- •Normal renal function and liver function tests.
- •Age 18 or older.
- •The effects of megestrol acetate on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because megestrol acetate is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
排除标准
- •Prior complex atypical endometrial hyperplasia or carcinoma.
- •Prior hormone sensitive malignancy.]
- •Exogenous estrogen or progestin use presently or within the past 12 months.
- •Standard contraindications to progestin therapy.
- •Standard contraindications to intrauterine device use.
- •Simple hyperplasia, complex hyperplasia without atypia (may be present in addition to atypical endometrial hyperplasia).
- •Endometrial carcinoma (worrisome or possible carcinoma not exclusionary but requires dilatation and curettage if based only on office biopsy).
- •Pregnant women are excluded from this study because megestrol acetate has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with megestrol acetate, breastfeeding should be discontinued if the mother is treated with megestrol acetate.
研究组 & 干预措施
Megestrol Acetate Arm - Control Arm
Megestrol Acetate 160 mg by mouth daily
干预措施: Megestrol Acetate (Drug)
Levonorgestrel IUD - Comparison Arm
Levonorgestrel intrauterine device with 52 mg progestin (Releases 20mcg/daily)
干预措施: Levonorgestrel Drug Implant (Drug)
结局指标
主要结局
Histologic Response Scoring of Biopsy Specimens
时间窗: 6 months
The primary outcome is a response score (0: no response, 1: incomplete response, 2: complete response): Score -1 will be assigned to specimens with progression of disease (ie. Endometrial carcinoma); Score 0 will be assigned to specimens with atypical hyperplasia; Score 1 will be assigned to specimens with benign hyperplasia and will be indicative partial response to therapy; Score 2 will be assigned to specimens without hyperplasia and will be indicative of complete response to therapy. All study cases will be reviewed by a pathologist and all cases will be scored following the standard 2014 WHO classification of endometrial hyperplasia. Investigators will compare the estimated 90% confidence interval (CI) of the levonorgestrel-releasing Intrauterine system versus the standard therapy from the noninferiority trial to a predefined margin.
次要结局
- Number of Toxicities for Each Treatment(Up to 8 months)
- Pathological Response to Treatment(Up to 8 months)