Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pelvic pain
研究概览
简要总结
To evaluate the efficacy of oral contraceptives in a continuous fashion versus the usual cyclic fashion in the recurrence of endometriosis related symptoms and endometriomas following fertility-sparing surgery.
详细描述
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free (cyclic fashion) or one tablet a day in a continuous fashion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age with Symptomatic endometriosis following fertility sparing surgery
排除标准
- •Contraindications of use of oral contraceptives
研究组 & 干预措施
Oral contraceptives cyclic
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial.
干预措施: Oral contraceptives cyclic (Drug)
Oral contraceptives cyclic
Oral contraceptives containing 0.03 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for 21 days followed by 7 days pill free. The regimen will be repeated for the duration of the trial.
干预措施: Oral contraceptives continuous (Drug)
Oral contraceptives continuous
Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial.
干预措施: Oral contraceptives cyclic (Drug)
Oral contraceptives continuous
Oral contraceptives containing 0.030 mg ethinyl estradiol and 3mg drospirenone will be administered. One tablet a day for the duration of the trial.
干预措施: Oral contraceptives continuous (Drug)
结局指标
主要结局
Pelvic pain
时间窗: 6 months
In each visit patients will complete a detailed 25-item self-administered questionnaire (www.endometriosisfoundation.org/WERF-WHSS-Questionnaire-English.pdf) related to the presence of pelvic pain (scoring of pelvic pain)
次要结局
- recurrence rate for endometrioma(6 months)
研究者
Nikos Vlahos
M.D, F.A.C.O.G Ass. Professor of Gynecology and Obstetrics
University of Athens