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临床试验/CTRI/2024/02/062618
CTRI/2024/02/062618Not Applicable4 期

Efficacy of a cyclic regimen of Dienogest for treatment of adenomyosis

Songklanagarind hospital1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2024年2月23日最近更新:

试验速览

阶段
4 期
状态
Not Applicable
发起方
入组人数
23
试验地点
1
主要终点
To evaluate the change in visual analog scale (VAS) of dysmenorrhea during treatment women diagnosed with adenomyosis by cyclic regimen of dienogest

研究概览

简要总结

Adenomyosis is a benign uterine disease which causes disturbing symptoms for premenopausal women. The common two symptoms are dysmenorrhea and heavy menstrual bleeding which can be severe and impair quality of life. The etiology of adenomyosis is suspected from the endometrial gland and stromal that invade uterine myometrium which cause pain symptom and heavy bleeding on menstruation.

Dienogest is the fourth generation of oral progestogen which can cause endometrial decidualization and atrophy. Several previous studies stated that continuous regimen of dienogest was efficacious to treat adenomyosis in terms of reducing dysmenorrhea and heavy menstrual bleeding. However, dienogest has also been shown to have high undesirable side effects. Irregular bleeding or spotting is the main side effect which can be found in more than half of the patients and leads to discontinuation of treatment.

Cyclic regimen of dienogest, 3-week period with 1-week withdrawal period, to reduce irregular bleeding during treatment of endometriosis was evaluated. It could significantly ameliorate the menstrual pain compared with that before treatment and also resulted in high occurrence of menstrual-lilke bleeding during the drug withdrawal period with less number of days of irregular bleeding. However, the efficacy of a cyclic regimen of dienogest has not yet been studied for treatment of adenomyosis. Many of the pathophysiology of adenomyosis and endometriosis is quite similar. Both are originated from eutopic endometrium having somatic mutation and migrating to different sites e.g. peritoneal surface, ovary or myometrium. Therefore, this study aims to evaluate the efficacy of a cyclic regimen of dienogest for treatment of adenomyosis.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • 1.Adenomyosis is diagnosed by ultrasound 2.Dysmenorrhea with visual analog scale more than 3 3.Woman with regular frequency of menstruation 24-38 days for 3 cycles 4.No pregnancy desire during the treatment and trial period 5.No co-existing endometrioma or myoma or current PID by pelvic examination and ultrasonography.

排除标准

  • 1.Contraindication of dienogest 2.Previous hormonal treatment within 3 months or current use 3.History or suspicious of gynecologic malignancy or hormonal responsive tumor 4.Currently breastfeeding 5.Current use of drugs with interaction to cytochrome P450.

结局指标

主要结局

To evaluate the change in visual analog scale (VAS) of dysmenorrhea during treatment women diagnosed with adenomyosis by cyclic regimen of dienogest

时间窗: 3 months

次要结局

  • To evaluate patterns and amount of uterine bleeding during treatment with cyclic regimen of dienogest.(3 months)
  • To evaluate adverse effect of cyclic regimen of dienogest.(3 months)

研究者

发起方
Songklanagarind hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Pakhanan Dankamak

Songklanagarind hospital

研究点 (1)

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