Dienogest Versus a Low-dose Combined Oral Contraceptive for Treatment of Adenomyotic Uteri
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of women who will improved from the pelvic pain measured by visual analogue scale
研究概览
简要总结
Adenomyosis is a common disease in women aged 40-50 years. It associates with dysmenorrhea and menorrhagia. Hysterectomy was considered the main treatment that could definitively cure this disease. Other treatment options are increasingly offered, including hormonal suppression with gonadotropin-releasing hormone agonists or danazol and endometrial ablation. However, deep adenomyosis responds weakly to the above treatment options, which are commonly not considered for long-term management because of the associated side effects.
Dienogest is a progestin medication which is used in birth control pills and in the treatment of endometriosis and adenomyosis. Low-dose combined oral contraceptive (COC) pills have been widely used as the primary treatment for menorrhagia. COCs can also be used to induce endometrial atrophy and to decrease endometrial prostaglandin production, which can consequently improve menorrhagia and dysmenorrhea that are associated with adenomyosis
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-40 years
- •Women with ultrasonographic evidence of adenomyosis
- •Woman complains of vaginal bleeding or pelvic pain related to adenomyosis
排除标准
- •Women with a history of malignancy or histological evidence of endometrial hyperplasia
- •any adnexal abnormality on ultrasound
- •undiagnosed vaginal
- •contraindication to receive Vissane or gynera .
研究组 & 干预措施
Dienogest group
干预措施: Dienogest group (Drug)
Dienogest group
干预措施: Ultrasound (Radiation)
Dienogest group
干预措施: visual analogue scale (Other)
Gynera group
干预措施: Gestodene-Ethinyl Estradiol (Drug)
Gynera group
干预措施: Ultrasound (Radiation)
Gynera group
干预措施: visual analogue scale (Other)
结局指标
主要结局
Number of women who will improved from the pelvic pain measured by visual analogue scale
时间窗: 6 months
次要结局
- Uterine volume (cm 3 ) measure by ultrasound(6 month)
研究者
Mohammed Khairy Ali
Lecturer
Assiut University