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

NCT02027337 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-11-21

No results posted yet for this study

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

Conditions

  • Polycystic Ovarian Syndrome
  • Hyperandrogenism
  • Menstrual Irregularities

Interventions

DRUG

20 mcg ethinylestradiol /3 mg drospirenone

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

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.

DRUG

30 mcg ethinylestradiol/3 mg drospirenone

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

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.

DRUG

35 mcg ethinylestradiol/2 mg cyproterone

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

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.

Sponsors & Collaborators

  • Tyumen State Medical Academy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-03-31
Completion
2015-10-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02027337 on ClinicalTrials.gov