Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

NCT03383185 — Completed, 489 participants, Federal University of São Paulo

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Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives, 5-year Follow-up

Registry	NCT03383185
Status	Completed
Study type	Observational
Enrollment	489 (Actual)
Sponsor	Federal University of São Paulo (Other)
Conditions	Contraceptive Usage, Metabolic Syndrome, Body Weight Changes
Interventions	Intrauterine device, Combined Oral Contraceptive, Progestin-only pills, Depot-Medroxyprogestereone Acetate (Device, drug)
Dates	start 2010-01-01, primary completion 2015-01-01, completion 2015-01-01, first posted 2017-12-26, last updated 2017-12-26
Locations	1 site in Brazil

-Summary

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

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Non-hormonal contraceptive		Device: Intrauterine device	Users of non- hormonal intrauterine device during the 5 years follow-up
Hormonal contraceptives		Drug: Combined Oral Contraceptive; Drug: Progestin-only pills; Drug: Depot-Medroxyprogestereone Acetate	Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up

Intrauterine device (Device): Use of Intrauterine device during the follow-up period
Combined Oral Contraceptive (Drug): Use of combined oral contraceptive during the follow-up period
Progestin-only pills (Drug): Use of progestin-only pills during the follow-up period
Depot-Medroxyprogestereone Acetate (Drug): Use of depot-medroxyprogesterone acetato during the follow-up period

+Outcome measures

Primary outcomes

Body Mass Index [five years follow-up]: evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives

Secondary outcomes

glycemia [five years follow-up]: evaluation of variation of glycemia during the usage of hormonal and non-hormonal contraceptives
cholesterol level [five years follow-up]: evaluation of variation of cholesterol serum levels during the usage of hormonal and non-hormonal contraceptives
triglycerides level [five years follow-up]: evaluation of variation of triglycerides serum levels during the usage of hormonal and non-hormonal contraceptives

+Eligibility

Sex: Female, ages: 18 Years to 45 Years, accepts healthy volunteers

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)

Facility	City	Country	Status
Federal University of Sao Paulo - Unifesp	São Paulo, São Paulo	Brazil