Polycystic Ovarian Syndrome Clinical Trial
Official title:
The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
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
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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