search
Back to results

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

Primary Purpose

Polycystic Ovarian Syndrome, Hyperandrogenism, Menstrual Irregularities

Status
Unknown status
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
20 mcg ethinylestradiol /3 mg drospirenone
20 mcg ethinylestradiol/3 mg drospirenone and Selmevit
30 mcg ethinylestradiol/3 mg drospirenone
30 mcg ethinylestradiol/3 mg drospirenone and Selmevit
35 mcg ethinylestradiol/2 mg cyproterone
35 mcg ethinylestradiol/2 mg cyproterone and Selmevit
Sponsored by
Tyumen State Medical Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polycystic Ovarian Syndrome focused on measuring combined oral contraceptives, drospirenone, cyproterone, hemostasis, antioxidants

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts 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)

Sites / Locations

  • Tyumen State Medical AcademyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Control group

20 mcg EE/3 mg drospirenone

20 mcg EE/3 mg drospirenone and Selmevit

30 mcg EE/3 mg drospirenone

30 mcg EE/3 mg drospirenone and Selmevit

35 mcg EE/2mg cyproterone

35 mcg EE/2 mg cyproterone and Selmevit

Arm Description

Healthy women that no use combined oral contraceptives

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Change from Baseline in Activated recalcification time
Change from Baseline in Activated partial thromboplastin time
Change from Baseline in Prothrombin time
Change from Baseline in International normalized ratio
Change from Baseline in D-dimer concentration
Change from Baseline in Fibrinogen concentration
Change from Baseline in Soluble fibrin-monomer complexes concentration
Change from Baseline in Platelet aggregation
Change from Baseline in Antithrombin III activity
Change from Baseline in Reserve plasminogen index
Change from Baseline in Erythrocyte Lipoperoxidation products, extractable in heptane and isopropanol
Change from Baseline in Malondialdehyde Concentration in Erythrocytes
Change from Baseline in Glutathion-S-transferase Activity in Erythrocytes
Change from Baseline in Superoxide dismutase Activity in Erythrocytes
Vitamin A and E plasma concentration

Secondary Outcome Measures

Frequency of adverse effects
Subjective tolerability of contraceptives

Full Information

First Posted
December 26, 2013
Last Updated
November 20, 2014
Sponsor
Tyumen State Medical Academy
search

1. Study Identification

Unique Protocol Identification Number
NCT02027337
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tyumen State Medical Academy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Hyperandrogenism, Menstrual Irregularities
Keywords
combined oral contraceptives, drospirenone, cyproterone, hemostasis, antioxidants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Healthy women that no use combined oral contraceptives
Arm Title
20 mcg EE/3 mg drospirenone
Arm Type
Experimental
Arm Description
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz)
Arm Title
20 mcg EE/3 mg drospirenone and Selmevit
Arm Type
Experimental
Arm Description
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/3 mg drospirenone (Yaz) and antioxidant complex Selmevit
Arm Title
30 mcg EE/3 mg drospirenone
Arm Type
Experimental
Arm Description
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin)
Arm Title
30 mcg EE/3 mg drospirenone and Selmevit
Arm Type
Experimental
Arm Description
Women that use combined oral contraceptives containing 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin) and antioxidant complex Selmevit
Arm Title
35 mcg EE/2mg cyproterone
Arm Type
Experimental
Arm Description
Women that use combined oral contraceptives containing 35 mcg ethinylestradiol/2 mg cyproterone
Arm Title
35 mcg EE/2 mg cyproterone and Selmevit
Arm Type
Experimental
Arm Description
Women that use combined oral contraceptives containing 20 mcg ethinylestradiol/2 mg cyproterone and Selmevit
Intervention Type
Drug
Intervention Name(s)
20 mcg ethinylestradiol /3 mg drospirenone
Other Intervention Name(s)
Yaz
Intervention Description
One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
Intervention Type
Drug
Intervention Name(s)
20 mcg ethinylestradiol/3 mg drospirenone and Selmevit
Other Intervention Name(s)
Yaz, Selmevit
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
30 mcg ethinylestradiol/3 mg drospirenone
Other Intervention Name(s)
Yasmin
Intervention Description
One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
Intervention Type
Drug
Intervention Name(s)
30 mcg ethinylestradiol/3 mg drospirenone and Selmevit
Other Intervention Name(s)
Yasmin, Selmevit
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
35 mcg ethinylestradiol/2 mg cyproterone
Other Intervention Name(s)
Diane-35, Chloe
Intervention Description
1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
Intervention Type
Drug
Intervention Name(s)
35 mcg ethinylestradiol/2 mg cyproterone and Selmevit
Other Intervention Name(s)
Diane-35, Chloe, Selmevit
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Title
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)
Secondary Outcome Measure Information:
Title
Frequency of adverse effects
Time Frame
12 cycles of 4 weeks
Title
Subjective tolerability of contraceptives
Time Frame
12 cycles of 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatyana N Khvoschina
Email
hvoschina-t@yandex.ru
Facility Information:
Facility Name
Tyumen State Medical Academy
City
Tyumen
ZIP/Postal Code
3452
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatyana N Khvoschina
Email
hvoschina-t@yandex.ru
First Name & Middle Initial & Last Name & Degree
Tatyana N Khvoschina

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs