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临床试验/NCT04451746
NCT04451746已完成不适用

The Influence of Combined Oral Contraception on the DEvelopment and progRession of Chronic venoUs diSeases

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2020年6月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
Development and progression of chronic venous diseases

研究概览

简要总结

Investigation of the influence of combined oral contraception on the development and progression of chronic venous diseases

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
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

入选标准

  • The investigators consistently include patients who have been prescribed hormonal tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 +
  • Clinical class C0-1 according to CEAP;
  • 2) Able to come for checkups every 3 months; 3) The presence of informed consent.

排除标准

  • Age up to 45 years;
  • A history of surgical treatment of veins of the lower extremities;
  • Clinical class C2 and higher according to CEAP;
  • History of DVT or PE;
  • Aplasia or angio-dysplasia of deep veins;
  • Restriction of mobility;
  • Arterial insufficiency;
  • Oncological diseases.

研究组 & 干预措施

Tableted hormonal drugs for contraception

Other

Tableted hormonal drugs for contraception, 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.

干预措施: Combined Oral Contraceptive (Drug)

结局指标

主要结局

Development and progression of chronic venous diseases

时间窗: 1 year

次要结局

  • Deep venous thrombosis(1 year)

研究者

发起方
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Borsuk

Clinic of Phlebology and Laser Surgery

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

研究点 (1)

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