NCT02027337

Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants

The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tyumen State Medical Academy · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Polycystic Ovarian Syndrome
• Hyperandrogenism
• Menstrual Irregularities

Interventions

Type	Name	Description
DRUG	20 mcg ethinylestradiol /3 mg drospirenone	One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
DRUG	20 mcg ethinylestradiol/3 mg drospirenone and Selmevit	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.
DRUG	30 mcg ethinylestradiol/3 mg drospirenone	One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
DRUG	30 mcg ethinylestradiol/3 mg drospirenone and Selmevit	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.
DRUG	35 mcg ethinylestradiol/2 mg cyproterone	1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
DRUG	35 mcg ethinylestradiol/2 mg cyproterone and Selmevit	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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-10-01
• First posted: 2014-01-06
• Last updated: 2014-11-21

Locations

1 site across 1 country: Russia