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

Polycystic Ovarian Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02027337
• Other study ID #: 01200707998
• Status: Recruiting
• Phase: Phase 4
• First received: December 26, 2013
• Last updated: November 20, 2014
• Start date: December 2013
• Est. completion date: October 2015

Study information

• Verified date: January 2014
• Source: Tyumen State Medical Academy
• Contact: Tatyana N Khvoschina
• Email: hvoschina-t[@]yandex.ru
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hyperandrogenism
• Menstrual Irregularities
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Russian Federation	Tyumen State Medical Academy	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Tyumen State Medical Academy

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Activated recalcification time		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Activated partial thromboplastin time		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Prothrombin time		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in International normalized ratio		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in D-dimer concentration		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Fibrinogen concentration		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Soluble fibrin-monomer complexes concentration		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Platelet aggregation		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Antithrombin III activity		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Reserve plasminogen index		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Malondialdehyde Concentration in Erythrocytes		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Change from Baseline in Superoxide dismutase Activity in Erythrocytes		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Primary	Vitamin A and E plasma concentration		Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)	Yes
Secondary	Frequency of adverse effects		12 cycles of 4 weeks	Yes
Secondary	Subjective tolerability of contraceptives		12 cycles of 4 weeks	Yes