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临床试验/NCT06378489
NCT06378489尚未招募不适用

The Etonogestrel Contraceptive Implant for Treatment of Endometrial Hyperplasia Without Atypia: A Single-arm, Open-label, Longitudinal Study in a Government Hospital in the Philippines

University of the Philippines0 个研究点目标入组 60 人开始时间: 2024年6月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Endometrial thickness (by ultrasound)

研究概览

简要总结

Endometrial hyperplasia without atypia is a condition in which the endometrium (the lining of the uterus) becomes abnormally thick. Although endometrial hyperplasia without atypia is not cancer, it can lead to endometrial cancer in 1-3% of women. This disease is treated by giving progestins. The optimal route, dosage and duration of progestin treatment for endometrial hyperplasia has not yet been determined until now. However, several publications have suggested the use of levonorgestrel releasing IUD as first-line treatment for endometrial hyperplasia without atypia. The other common medications used are the oral progestins medroxyprogesterone (MPA) and norethisterone acetate (NETA).

The etonogestrel implant (Implant NXT) has been approved for contraceptive use by the US FDA in 2006. The mchanism of action of the implant for contraception suggests a potential application for its use in the treatment on hyperplasia. Off-label use of the implant for adrnomyosis, endometriosis and chronic pelvic pain has already been described in various studies. However, its therapeutic effect on endometrial hyperplasia without atypia has not been studied yet. The researchers propose to use the etonogestrel implant (Implant NXT) as novel treatment for endometrial hyperplasia without atypia. The study aims to determine the rate of regression to normal endometrium among patients with endometrial hyperplasia without atypia at 3 and 6 months after insertion of the implant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women aged 18 years old to perimenopause who present with or without abnormal uterine bleeding and who have an endometrial biopsy result which shows endometrial hyperplasia without atypia
  • women willing to have the etonogestrel implant (Implant NXT) for the duration of treatment (6-12 months)
  • women who wish to retain their uterus

排除标准

  • 未提供

结局指标

主要结局

Endometrial thickness (by ultrasound)

时间窗: At three and six months after insertion of the implant

Performed by expert sonologist

Rate of (resolution) regression to normal endometrium

时间窗: 3 months after the insertion of the implant

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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