A Phase 4 interventional study of 20 mcg ethinylestradiol /3 mg drospirenone and 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit in Polycystic Ovarian Syndrome, Hyperandrogenism and Menstrual Irregularities, sponsored by Tyumen State Medical Academy. Status unknown at 1 site in Russian Federation. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-21.
Sponsored by Tyumen State Medical Academy · Phase 4, Interventional, and Prevention
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
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.
This study's planned enrollment of 200 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →This is the only study on the registry with Tyumen State Medical Academy as lead sponsor.
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Exclusion Criteria:
Healthy women that no use combined oral contraceptives
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz)
Drug: 20 mcg ethinylestradiol /3 mg drospirenone
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit
Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)
Drug: 30 mcg ethinylestradiol/3 mg drospirenone
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit
Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit
Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone
Drug: 35 mcg ethinylestradiol/2 mg cyproterone
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit
Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
Also known as: Yaz
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.
Also known as: Yaz, Selmevit
One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
Also known as: Yasmin
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.
Also known as: Yasmin, Selmevit
1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
Also known as: Diane-35, Chloe
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.
Also known as: Diane-35, Chloe, Selmevit
Change from Baseline in Activated recalcification time
Time frame: 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
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Prothrombin time
Time frame: 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
Time frame: 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
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Fibrinogen concentration
Time frame: 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
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Change from Baseline in Platelet aggregation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Vitamin A and E plasma concentration
Time frame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Frequency of adverse effects
Time frame: 12 cycles of 4 weeks
Subjective tolerability of contraceptives
Time frame: 12 cycles of 4 weeks
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