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

November 20, 2014 updated by: Khvoschina Tatyana N., Tyumen State Medical Academy

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Tyumen, Russian Federation, 3452
        • Recruiting
        • Tyumen State Medical Academy
        • Contact:
        • Principal Investigator:
          • Tatyana N Khvoschina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
Healthy women that no use combined oral contraceptives
EXPERIMENTAL: 20 mcg EE/3 mg drospirenone
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz)
Drug: 20 mcg ethinylestradiol /3 mg drospirenone
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
Other Names:
  • Yaz
EXPERIMENTAL: 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
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
EXPERIMENTAL: 30 mcg EE/3 mg drospirenone
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)
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
EXPERIMENTAL: 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
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
EXPERIMENTAL: 35 mcg EE/2mg cyproterone
Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone
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
EXPERIMENTAL: 35 mcg EE/2 mg cyproterone and Selmevit
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit
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
  • Selmevit
  • Chloe

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of adverse effects
Time Frame: 12 cycles of 4 weeks
12 cycles of 4 weeks
Subjective tolerability of contraceptives
Time Frame: 12 cycles of 4 weeks
12 cycles of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tyumen State Medical Academy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2015

Study Completion (ANTICIPATED)

October 1, 2015

Study Registration Dates

First Submitted

December 26, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01200707998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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