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The Effect of Hormonal Contraception on Female

NCT01852786 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2013-05-14

No results posted yet for this study

Summary

The aim- To evaluate the impact of combined oral contraceptives on women's psychosexual, metabolic, blood coagulation, hormonal and genetic measures.

Combined oral contraceptives (COCs) is still the most popular contraception method. It is possible to find a number of publications about their non-contraceptive benefits, also about their adverse events. Most researches are conducted during clinical trials, which are commissioned by pharmaceutical companies, in order to compare COCs of different composition. This study set out to assess the role of psychosexual, metabolic, endocrine, hormonal and genetic measures of low dose combined oral contraceptive users- 20 micrograms of Ethinylestradiol/3 mg of Drospirenone and 20 micrograms of Ethinylestradiol/75 micrograms of Gestoden. Because this study is not commercial, it is expected to obtain valuable objective data - there are very few comparative studies about the impact of COCs to woman's organism.

Conditions

  • Adverse Effect of Oral Contraceptives, Initial Encounter

Interventions

OTHER

Contraceptives, Oral, Combined

• The women, presenting for hormonal contraception use and with no contraindications for hormonal therapy, one of the two medicines registered in Lithuania will be administered׃ Daylette (20 micrograms of Ethinylestradiol and 3 mg of Drospirenone) or Lindynette (20 micrograms of Ethinylestradiol and 75 micrograms of Gestoden).

OTHER

Controls

The women, The women presenting for non-hormonal contraception use, will be recommended BCM or NFPM.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Birute Zilaitiene, Ass. Proff. · Lithuanian University of Health Sciences, Institute of Endocrinology

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-02-28
Completion
2016-02-29

Countries

  • Lithuania

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 NCT01852786 on ClinicalTrials.gov