NCT02027337

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 21, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

December 26, 2013

Last Update Submit

November 20, 2014

Conditions

Polycystic Ovarian SyndromeHyperandrogenismMenstrual Irregularities

Keywords

combined oral contraceptivesdrospirenonecyproteronehemostasisantioxidants

Outcome Measures

Primary Outcomes (15)

  • 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)

  • 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)

  • Change from Baseline in Prothrombin time

    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

    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

    Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)

  • Change from Baseline in Fibrinogen concentration

    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

    Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)

  • Change from Baseline in Platelet aggregation

    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

    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

    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

    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

    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

    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

    Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)

  • Vitamin A and E plasma concentration

    Baseline, 1, 3, 6 and 12 cycles of 4 weeks (between days 18 and 21 of each cycle)

Secondary Outcomes (2)

  • Frequency of adverse effects

    12 cycles of 4 weeks

  • Subjective tolerability of contraceptives

    12 cycles of 4 weeks

Study Arms (7)

Control group

NO INTERVENTION

Healthy women that no use combined oral contraceptives

20 mcg EE/3 mg drospirenone

EXPERIMENTAL

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

Drug: 20 mcg ethinylestradiol /3 mg drospirenone

20 mcg EE/3 mg drospirenone and Selmevit

EXPERIMENTAL

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

30 mcg EE/3 mg drospirenone

EXPERIMENTAL

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

Drug: 30 mcg ethinylestradiol/3 mg drospirenone

30 mcg EE/3 mg drospirenone and Selmevit

EXPERIMENTAL

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

35 mcg EE/2mg cyproterone

EXPERIMENTAL

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

Drug: 35 mcg ethinylestradiol/2 mg cyproterone

35 mcg EE/2 mg cyproterone and Selmevit

EXPERIMENTAL

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

Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit

Interventions

20 mcg ethinylestradiol /3 mg drospirenoneDRUG

One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12

Also known as: Yaz
20 mcg EE/3 mg drospirenone
20 mcg ethinylestradiol/3 mg drospirenone and SelmevitDRUG

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.

Also known as: Yaz, Selmevit
20 mcg EE/3 mg drospirenone and Selmevit
30 mcg ethinylestradiol/3 mg drospirenoneDRUG

One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12

Also known as: Yasmin
30 mcg EE/3 mg drospirenone
30 mcg ethinylestradiol/3 mg drospirenone and SelmevitDRUG

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.

Also known as: Yasmin, Selmevit
30 mcg EE/3 mg drospirenone and Selmevit
35 mcg ethinylestradiol/2 mg cyproteroneDRUG

1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12

Also known as: Diane-35, Chloe
35 mcg EE/2mg cyproterone
35 mcg ethinylestradiol/2 mg cyproterone and SelmevitDRUG

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.

Also known as: Diane-35, Chloe, Selmevit
35 mcg EE/2 mg cyproterone and Selmevit

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 18-35 years
  • Absence of contraindications for COC use
  • Informed voluntary consent for examination

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tyumen State Medical Academy

Tyumen, 3452, Russia

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeHyperandrogenismMenstruation Disturbances

Interventions

Ethinyl Estradioldrospirenone and ethinyl estradiol combinationCyproterone acetate, ethinyl estradiol drug combination

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NorpregnatrienesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsEstrogenic Steroids, AlkylatedEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Tatyana N Khvoschina

CONTACT

hvoschina-t@yandex.ru

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tyumen State Medical Academy

Study Record Dates

First Submitted

December 26, 2013

First Posted

January 6, 2014

Study Start

December 1, 2013

Primary Completion

March 1, 2015

Study Completion

October 1, 2015

Last Updated

November 21, 2014

Record last verified: 2014-01

Locations

RU(1)