Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

Federal University of São Paulo489 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

489

Conditions

Contraceptive Usage Metabolic Syndrome Body Weight Changes

Interventions

Intrauterine deviceDEVICE

Use of Intrauterine device during the follow-up period

Combined Oral ContraceptiveDRUG

Use of combined oral contraceptive during the follow-up period

Progestin-only pillsDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, Brazil

Outcomes

Primary Outcomes

Body Mass Index

evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives

Time frame: five years follow-up

Secondary Outcomes

glycemia

evaluation of variation of glycemia during the usage of hormonal and non-hormonal contraceptives

Time frame: five years follow-up

cholesterol level

evaluation of variation of cholesterol serum levels during the usage of hormonal and non-hormonal contraceptives

Time frame: five years follow-up

triglycerides level

evaluation of variation of triglycerides serum levels during the usage of hormonal and non-hormonal contraceptives

Time frame: five years follow-up

Data from ClinicalTrials.gov

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