Maintenance Therapy of LNG-IUS in Conjunction With the GnRH Agonist to Prevent the Recurrence of Symptomatic Endometriosis After Conservative Surgery: A Prospective Randomized, Phase III Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recurrence rate of endometriosis
研究概览
简要总结
The recurrence rates of endometriosis reported in women 5 years after therapy with gonadotropin releasing hormone (GnRH) agonist were 74% for severe disease . No strategies to prevent the recurrence of endometriosis have been uniformly successful. Local progesterone treatment of endometriosis-associated dysmenorrhea with a levonorgestrel-releasing intrauterine system (LNG-IUS) for 12 months has resulted in a significant reduction in dysmenorrhea, pelvic pain and dyspareunia; a high degree of patient satisfaction; and a significant reduction in the volume of rectovaginal endometriotic nodules. LNG-IUS may become a more important option if a long-term medical suppression of endometriosis.
Based on literature review, I hypothesized that maintenance therapy of LNG-IUS in conjunction with the GnRH agonist could lower the recurrence rates endometriosis after conservative surgery. We try to answer the question whether maintenance therapy of LNG-IUS in conjunction with the GnRH agonist could lower the recurrence rates and thus extend the symptom-free interval (menorrhagia and dysmenorrhea) as compared to GnRH agonist alone after conservative surgery in severe endometriosis cases.
详细描述
Participants:
This post-surgical medical therapy trial will be undertaken among patients with moderate-severe symptomatic endometriosis (rASRM score >16, according to the American Society for Reproductive Medicine) or adenomyosis. Symptomatic endometriosis means menorrhagia or dysmenorrhea. All patients were surgically treated by a conservative approach (means preserve uterus and ovary).
Interventions:
In all patients, were prescribed 600 mg elemental Ca and 400 IU vitamin D (bid). The first group of patients receive LNG-IUS for 5 years and GnRH agonist (triptorelin 3.75 mg, sc q28day) for 24 weeks.
The second group of patients receive GnRH agonist (triptorelin 3.75 mg, sc q28day) alone for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate-severe symptomatic endometriosis (rASRM score >16) according to the American Society for Reproductive Medicine) or adenomyosis. Symptomatic endometriosis means menorrhagia or dysmenorrhea.
- •All patients were surgically treated by a conservative approach.
- •Levels of serum CA125 is higher than normal range.
排除标准
- •Further desire for child bearing in future 3 years.
- •Any treatment for endometriosis within the previous 2 months.
- •Any concomitant disease that can be an established cause of chronic pelvic pain and anemia (Thalassemia anemia, inflammation sequela, myoma , and pelvic congestion etc)
研究组 & 干预措施
LNG-IUS
LNG-IUS insertion during conservative surgery and GnRH agonist 6 doses.
干预措施: LNG-IUS (Device)
LNG-IUS
LNG-IUS insertion during conservative surgery and GnRH agonist 6 doses.
干预措施: GnRH agonist (triptorelin) (Drug)
GnRH agonist
The second group of patients receive GnRH agonist (triptorelin 3.75 mg, sc q28day) alone for 24 weeks.
干预措施: GnRH agonist (triptorelin) (Drug)
结局指标
主要结局
Recurrence rate of endometriosis
时间窗: 2 years
We will follow the patients for 2 years, after the end of GnRH agonist medical treatment. Number of Participants with recurrence as a Measure of the clinical efficacy of LNG-IUS maintenance therapy to prevent recurrence of endometriosis.
次要结局
- the safety of LNG-IUS maintenance therapy to prevent recurrence of endometriosis.(2 years)