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Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

NCT ID: NCT03383185

Last Updated: 2017-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

489 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2015-01-01

Brief Summary

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Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during five years follow-up

Detailed Description

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Were eligible for the study 489 Women, followed in Federal University of São Paulo Family Planning Service, who used the same contraceptive method during five year of follow-up, According to the service protocol, the patients, after had participated of a orientation group about contraceptives methods, elected one of them. After that, if the choice had been according to the eligibility criteria of World Health Organization, it was approved by a gynecologist.

The contraceptive methods available were the intrauterine device (IUD) oral contraceptives, including combined pills and progestin-only formulations, and depot medroxyprogestereone acetate.

The study consisted in the evaluation of their medical records of weight, BMI, Blood pressure, glycemia, seric levels of cholesterol and triglycerides, during the five years, and in the comparison of the differences of these data between the contraceptive methods.

Conditions

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Contraceptive Usage Metabolic Syndrome Body Weight Changes

Keywords

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contraception Body mass index Metabolic Syndrome obesity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Non-hormonal contraceptive

Users of non- hormonal intrauterine device during the 5 years follow-up

Intrauterine device

Intervention Type DEVICE

Use of Intrauterine device during the follow-up period

Hormonal contraceptives

Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up

Combined Oral Contraceptive

Intervention Type DRUG

Use of combined oral contraceptive during the follow-up period

Progestin-only pills

Intervention Type DRUG

Use of progestin-only pills during the follow-up period

Depot-Medroxyprogestereone Acetate

Intervention Type DRUG

Use of depot-medroxyprogesterone acetato during the follow-up period

Interventions

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Intrauterine device

Use of Intrauterine device during the follow-up period

Intervention Type DEVICE

Combined Oral Contraceptive

Use of combined oral contraceptive during the follow-up period

Intervention Type DRUG

Progestin-only pills

Use of progestin-only pills during the follow-up period

Intervention Type DRUG

Depot-Medroxyprogestereone Acetate

Use of depot-medroxyprogesterone acetato during the follow-up period

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
* use of the same contraceptive method during five years

Exclusion Criteria

* incomplete data
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Ana Maria Homem de Mello Bianchi

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CAAE: 45523715.4.0000.5505

Identifier Type: -

Identifier Source: org_study_id