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Trial record 55 of 101 for:    DROSPIRENONE AND ETHINYL ESTRADIOL

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

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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

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

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Hyperandrogenism Menstrual Irregularities Drug: 20 mcg ethinylestradiol /3 mg drospirenone Drug: 20 mcg ethinylestradiol/3 mg drospirenone and Selmevit Drug: 30 mcg ethinylestradiol/3 mg drospirenone Drug: 30 mcg ethinylestradiol/3 mg drospirenone and Selmevit Drug: 35 mcg ethinylestradiol/2 mg cyproterone Drug: 35 mcg ethinylestradiol/2 mg cyproterone and Selmevit Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants
Study Start Date : December 2013
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : October 2015


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 Name: 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 Name: 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
  • Chloe
  • Selmevit




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]
  14. 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) ]
  15. 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 Measures :
  1. Frequency of adverse effects [ Time Frame: 12 cycles of 4 weeks ]
  2. Subjective tolerability of contraceptives [ Time Frame: 12 cycles of 4 weeks ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027337


Contacts
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Contact: Tatyana N Khvoschina hvoschina-t@yandex.ru

Locations
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Russian Federation
Tyumen State Medical Academy Recruiting
Tyumen, Russian Federation, 3452
Contact: Tatyana N Khvoschina       hvoschina-t@yandex.ru   
Principal Investigator: Tatyana N Khvoschina         
Sponsors and Collaborators
Tyumen State Medical Academy

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Responsible Party: Khvoschina Tatyana N., Tyumen State Medical Academy
ClinicalTrials.gov Identifier: NCT02027337     History of Changes
Other Study ID Numbers: 01200707998
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: January 2014
Keywords provided by Khvoschina Tatyana N., Tyumen State Medical Academy:
combined oral contraceptives
drospirenone
cyproterone
hemostasis
antioxidants
Additional relevant MeSH terms:
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Drospirenone
Drospirenone and ethinyl estradiol combination
Ethinyl Estradiol
Cyproterone acetate, ethinyl estradiol drug combination
Polycystic Ovary Syndrome
Hyperandrogenism
Menstruation Disturbances
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Pathologic Processes
Cyproterone Acetate
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Antioxidants
Cyproterone
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action