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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Healthy women that no use combined oral contraceptives | |
| 20 mcg EE/3 mg drospirenone | Experimental | Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) |
|
| 20 mcg EE/3 mg drospirenone and Selmevit | Experimental | Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit |
|
| 30 mcg EE/3 mg drospirenone | Experimental | Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) |
|
| 30 mcg EE/3 mg drospirenone and Selmevit | Experimental | Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mcg ethinylestradiol /3 mg drospirenone | Drug | One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Activated recalcification time | 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 | Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle) | |
| Change from Baseline in Prothrombin time | 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 | 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 | Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle) | |
| Change from Baseline in Fibrinogen concentration | 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 | Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle) | |
| Change from Baseline in Platelet aggregation | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse effects | 12 cycles of 4 weeks | |
| Subjective tolerability of contraceptives | 12 cycles of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tatyana N Khvoschina | Contact | hvoschina-t@yandex.ru |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tyumen State Medical Academy | Recruiting | Tyumen | 3452 | Russia |
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| 35 mcg EE/2mg cyproterone | Experimental | Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone |
|
| 35 mcg EE/2 mg cyproterone and Selmevit | Experimental | Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit |
|
| 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit | Drug | One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months. |
|
|
| 30 mcg ethinylestradiol/3 mg drospirenone | Drug | One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12 |
|
|
| 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit | Drug | One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12 Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months. |
|
|
| 35 mcg ethinylestradiol/2 mg cyproterone | Drug | 1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12 |
|
|
| 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit | Drug | One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months. |
|
|
| 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 | 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 | 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 | 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 | 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 | Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle) |
| Vitamin A and E plasma concentration | Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle) |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D017588 | Hyperandrogenism |
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| C534342 | drospirenone and ethinyl estradiol combination |
| C032640 | Cyproterone acetate, ethinyl estradiol drug combination |
| ID | Term |
|---|---|
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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