The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from Baseline in Fibrinogen concentration
研究概览
简要总结
We investigate parameters of hemocoagulation and lipoperoxidation in women using combined oral contraceptives with antiandrogenic activity (containing drospirenone with 20 or 30 mcg ethinylestradiol; or cyproterone acetate); correction of these changes by antioxidants
详细描述
It is well known that hormonal contraceptives using increase risk of thrombosis. We conduct parameters of hemostasis in women that use combined oral contraceptives with antiandrogenic activity for contraception and treatment. Considering relationship between lipoperoxidation in platelets and hemostasis we expect that limitation of lipoperoxidation by antioxidants can restrict hypercoagulation and decrease risk of thrombosis.
The purpose of this study is decrease of thrombosis risk in women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone, 30 mcg ethinylestradiol/3 mg drospirenone, 35 mcg ethinylestradiol/2mg cyproterone acetate. Half of the women of each arm (group) receive only combined oral contraceptives (COC), other women receive combined oral contraceptives and antioxidant complex Selmevit.
The blood tests conduct on 19-21 days of the menstrual cycle before COC use (control group) or on 19-21 days of COC use after 1, 3, 6 and 12 cycles.
Also we investigate subjective tolerability, therapeutic effects, menstrual cycle control and adverse effects of COCs in women that have or have no antioxidant complex Selmevit
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 18-35 years
- •Absence of contraindications for COC use
- •Informed voluntary consent for examination
排除标准
- •Age younger than 18 and older than 35 years
- •Refusal or failure to comply with the study protocol
- •Drug or alcohol dependence
- •Psychiatric diseases
- •Severe somatic and allergic diseases
- •Pregnancy
- •Malignancies
- •Taking drugs that affect haemostasis, including hormonal contraceptives during 6 months before study beginning
- •Cases of thrombosis among first-line relatives in family history
- •Contraindications to the COC use under Eligibility Criteria of hormonal contraception (WHO, 2012)
研究组 & 干预措施
20 mcg EE/3 mg drospirenone
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz)
干预措施: 20 mcg ethinylestradiol /3 mg drospirenone (Drug)
20 mcg EE/3 mg drospirenone and Selmevit
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit
干预措施: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit (Drug)
30 mcg EE/3 mg drospirenone
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)
干预措施: 30 mcg ethinylestradiol/3 mg drospirenone (Drug)
30 mcg EE/3 mg drospirenone and Selmevit
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit
干预措施: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit (Drug)
35 mcg EE/2mg cyproterone
Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone
干预措施: 35 mcg ethinylestradiol/2 mg cyproterone (Drug)
35 mcg EE/2 mg cyproterone and Selmevit
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit
干预措施: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit (Drug)
结局指标
主要结局
Change from Baseline in Fibrinogen concentration
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Antithrombin III activity
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Activated partial thromboplastin time
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Prothrombin time
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in International normalized ratio
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Soluble fibrin-monomer complexes concentration
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Platelet aggregation
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Malondialdehyde Concentration in Erythrocytes
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Activated recalcification time
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in D-dimer concentration
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Reserve plasminogen index
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Superoxide dismutase Activity in Erythrocytes
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Vitamin A and E plasma concentration
时间窗: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
次要结局
- Subjective tolerability of contraceptives(12 cycles of 4 weeks)
- Frequency of adverse effects(12 cycles of 4 weeks)
研究者
Khvoschina Tatyana N.
Tyumen State Medical Academy
Tyumen State Medical Academy