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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027337
Recruitment Status : Unknown
Verified January 2014 by Khvoschina Tatyana N., Tyumen State Medical Academy.
Recruitment status was:  Recruiting
First Posted : January 6, 2014
Last Update Posted : November 21, 2014
Sponsor:
Information provided by (Responsible Party):
Khvoschina Tatyana N., Tyumen State Medical Academy

Tracking Information
First Submitted Date  ICMJE December 26, 2013
First Posted Date  ICMJE January 6, 2014
Last Update Posted Date November 21, 2014
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02027337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • Frequency of adverse effects [ Time Frame: 12 cycles of 4 weeks ]
  • Subjective tolerability of contraceptives [ Time Frame: 12 cycles of 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives, Correction by Antioxidants
Official Title  ICMJE The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Polycystic Ovarian Syndrome
  • Hyperandrogenism
  • Menstrual Irregularities
Intervention  ICMJE
  • Drug: 20 mcg ethinylestradiol /3 mg drospirenone
    One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
    Other Name: 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 Name: 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
Study Arms  ICMJE
  • 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)
    Intervention: Drug: 20 mcg ethinylestradiol /3 mg drospirenone
  • 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
    Intervention: Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit
  • Experimental: 30 mcg EE/3 mg drospirenone
    Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)
    Intervention: Drug: 30 mcg ethinylestradiol/3 mg drospirenone
  • 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
    Intervention: Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit
  • Experimental: 35 mcg EE/2mg cyproterone
    Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone
    Intervention: Drug: 35 mcg ethinylestradiol/2 mg cyproterone
  • Experimental: 35 mcg EE/2 mg cyproterone and Selmevit
    Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit
    Intervention: Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 2, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02027337
Other Study ID Numbers  ICMJE 01200707998
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Khvoschina Tatyana N., Tyumen State Medical Academy
Study Sponsor  ICMJE Tyumen State Medical Academy
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tyumen State Medical Academy
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP