Trial | NCT02027337  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ethinyl estradiol drospirenone estradiol cyproviron multivitamins ...

  • Study Participants

    200
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
Study Started
Dec 31
2013
Primary Completion
Mar 31
2015
Anticipated
Study Completion
Oct 31
2015
Anticipated
Last Update
Nov 21
2014
Estimate

Drug 20 mcg ethinylestradiol /3 mg drospirenone

One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12

  • Other names: Yaz

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.

  • Other names: Yaz, Selmevit

Drug 30 mcg ethinylestradiol/3 mg drospirenone

One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12

  • Other names: Yasmin

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.

  • Other names: Yasmin, Selmevit

Drug 35 mcg ethinylestradiol/2 mg cyproterone

1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12

  • Other names: Diane-35, Chloe

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.

  • Other names: Diane-35, Chloe, Selmevit

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

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

Criteria 

Inclusion Criteria:

Women aged 18-35 years
Absence of contraindications for COC use
Informed voluntary consent for examination

Exclusion Criteria:

Age younger than 18 and older than 35 years
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)
No Results Posted