Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants
NCT ID: NCT02027337
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2013-12-31
2015-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Control group
Healthy women that no use combined oral contraceptives
No interventions assigned to this group
20 mcg EE/3 mg drospirenone
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz)
20 mcg ethinylestradiol /3 mg drospirenone
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
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
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.
30 mcg EE/3 mg drospirenone
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)
30 mcg ethinylestradiol/3 mg drospirenone
One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
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
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.
35 mcg EE/2mg cyproterone
Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone
35 mcg ethinylestradiol/2 mg cyproterone
1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
35 mcg EE/2 mg cyproterone and Selmevit
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit
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.
Interventions
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20 mcg ethinylestradiol /3 mg drospirenone
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
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.
30 mcg ethinylestradiol/3 mg drospirenone
One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
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.
35 mcg ethinylestradiol/2 mg cyproterone
1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Absence of contraindications for COC use
* Informed voluntary consent for examination
Exclusion Criteria
* 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)
18 Years
35 Years
FEMALE
Yes
Sponsors
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Tyumen State Medical Academy
OTHER
Responsible Party
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Khvoschina Tatyana N.
Tyumen State Medical Academy
Locations
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Tyumen State Medical Academy
Tyumen, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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01200707998
Identifier Type: -
Identifier Source: org_study_id