NCT06115408已完成2 期
Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- leiomyoma size reduction
研究概览
简要总结
This 2 arm randomized clinical trial will assess the impact of Dienogest and N-Acetyl Cysteine on volume reduction of uterine leiomyoma
详细描述
Group A women will receive Dienogest orally 2mg pills daily for 3 months .20 cases Group B women will receive NAC orally at a dose of 600 mg/day for 3 months ,20 cases
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 20-45 years.
- •Women with uterine leiomyoma (sub-mucous, sub-serous or intramural) based on transvaginal sonography criteria. Uterine fibroids most often appear as concentric, solid, hypoechoic masses. This appearance results from the prevailing muscle, which is observed at histologic examination. These solid masses absorb sound waves and therefore cause a variable amount of acoustic shadowing.
- •Regular menstruation: regular period interval from 21 to 35 days.
排除标准
- •Pregnant or menopausal women.
- •History of malignancies, metabolic, hematologic, cardiac, thromboembolism, diabetes, renal or hepatic diseases.
- •History of hormonal drug use or treatment for leiomyoma in the past 3 months.
研究组 & 干预措施
Drug;Dienogest
Experimental
2mg pills oral daily
干预措施: Dienogest 2 MG (Drug)
Drug;N-Acetylcysteine
Experimental
600 mg/day oral daily
干预措施: N-acetyl cysteine (Drug)
结局指标
主要结局
leiomyoma size reduction
时间窗: 3 months
vertical x horizontal diameter in mm by transvaginal U/S
次要结局
- Dysmenorrhea(3 Monthes)
- heavy menstrual bleeding(3 months)
- blood loss(3 months)
研究者
Esraa Mosaad Awd El-sayed
Researcher,ob/gyn Resident, Principal Investigator, Esraa Awd
Ain Shams University
研究点 (1)
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