Clinical trial NCT02027337: Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants
Official title: The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovarian Syndrome
Hyperandrogenism
Menstrual Irregularities
Keywords: combined oral contraceptives
drospirenone
cyproterone
hemostasis
antioxidants
Lead sponsor: Tyumen State Medical Academy
Sponsor class: OTHER
First posted: 2014-01-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility 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)

Primary outcomes:
measure: Change from Baseline in Activated recalcification time
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Activated partial thromboplastin time
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Prothrombin time
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in International normalized ratio
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in D-dimer concentration
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Fibrinogen concentration
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Soluble fibrin-monomer complexes concentration
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Platelet aggregation
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Antithrombin III activity
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Reserve plasminogen index
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Malondialdehyde Concentration in Erythrocytes
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Change from Baseline in Superoxide dismutase Activity in Erythrocytes
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
measure: Vitamin A and E plasma concentration
timeFrame: Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)
Secondary outcomes:
measure: Frequency of adverse effects
timeFrame: 12 cycles of 4 weeks
measure: Subjective tolerability of contraceptives
timeFrame: 12 cycles of 4 weeks
Other outcomes:
Locations:
city: Tyumen
country: Russian Federation
facility: Tyumen State Medical Academy
Study officials:
References: