跳至主要内容
临床试验/CTRI/2025/02/081131
CTRI/2025/02/081131尚未招募不适用

Novel use of Etonogestrel (ETN) Subdermal Implant (SDI) in adolescents and reproductive age group women with endometriosis and its comparison with Levonogestrel Intra-Uterine System (LNG-IUS) A non-inferiority prospective pilot study

ICMR1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
ICMR
入组人数
100
试验地点
1
主要终点
To study the efficacy of ETN-SDI in reducing endometriosis associated

研究概览

简要总结

This project aims to explore the effectiveness of Etonogestrel Subdermal Implant (ETN-SDI) as a treatment for endometriosis-related pain in adolescent and reproductive-age women. Endometriosis, which affects 10-15% of women, often causes significant pelvic pain, dysmenorrhea, and infertility. Currently, available treatments, like combined oral contraceptives (COCs) and LNG-IUS (Levonorgestrel Intra-Uterine System), have limitations, especially in adolescent populations. ETN-SDI, a long-acting contraceptive, has shown promise in reducing pain associated with endometriosis and may offer additional benefits as a reversible contraceptive.

The study will compare the efficacy of ETN-SDI and LNG-IUS in reducing endometriosis pain, using a non-inferiority prospective trial with 100 participants. It will also examine factors like acceptability, quality of life, bleeding patterns, and biomarkers such as CA-125 and BMD. Expected outcomes include ETN-SDI as a safe, cost-effective, long-term treatment for endometriosis and an effective contraceptive option. The study could have significant implications for adolescent health by expanding treatment options and addressing both pain and contraception needs in this population.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Patients clinically diagnosed with endometriosis (Complains of non-cyclical chronic pelvic pain and/or dysmenorrhea > 6 months) with either a) Radiological diagnosis of endometriosis based on TVS and MRI.
  • b) Surgically and histologically confirmed diagnosis of endometriosis.

排除标准

  • Not willing to participate in the study
  • Any known allergy to progesterone
  • Uterine fibroids
  • Endometrial polyps
  • Cardiovascular, hepatic, renal impairment, or any other contraindications and special warnings for treatment with Etonogestrel.

结局指标

主要结局

To study the efficacy of ETN-SDI in reducing endometriosis associated

时间窗: VAS SCORE ASSESSMENT

non-cyclic pain and dysmenorrhea as compared to LNG-IUS.

时间窗: VAS SCORE ASSESSMENT

次要结局

  • 1. To study the acceptability of ETN-SDI in participants (adolescent and reproductive(age women))

研究者

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Neha Varun

All India Institute of Medical Sciences, Delhi

研究点 (1)

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