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

Tyumen State Medical Academy

Status and phase: Unknown; Phase 4

Conditions: Hyperandrogenism; Menstrual Irregularities; Polycystic Ovarian Syndrome

Treatments: Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit; Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit; Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit; Drug: 30 mcg ethinylestradiol/3 mg drospirenone; Drug: 20 mcg ethinylestradiol /3 mg drospirenone; Drug: 35 mcg ethinylestradiol/2 mg cyproterone

Study type: Interventional

Funder types: Other

Identifiers

NCT02027337

01200707998

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 7 patient groups

Control group

No Intervention group

Description:

Healthy women that no use combined oral contraceptives

20 mcg EE/3 mg drospirenone

Experimental group

Description:

Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz)

Treatment:

Drug: 20 mcg ethinylestradiol /3 mg drospirenone

20 mcg EE/3 mg drospirenone and Selmevit

Experimental group

Description:

Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit

Treatment:

Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit

30 mcg EE/3 mg drospirenone

Experimental group

Description:

Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)

Treatment:

Drug: 30 mcg ethinylestradiol/3 mg drospirenone

30 mcg EE/3 mg drospirenone and Selmevit

Experimental group

Description:

Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit

Treatment:

Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit

35 mcg EE/2mg cyproterone

Experimental group

Description:

Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone

Treatment:

Drug: 35 mcg ethinylestradiol/2 mg cyproterone

35 mcg EE/2 mg cyproterone and Selmevit

Experimental group

Description:

Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit

Treatment:

Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit