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Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03383185
Enrollment
489
Registered
2017-12-26
Start date
2010-01-01
Completion date
2015-01-01
Last updated
2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraceptive Usage, Metabolic Syndrome, Body Weight Changes

Keywords

contraception, Body mass index, Metabolic Syndrome, obesity

Brief summary

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

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.

Interventions

DEVICEIntrauterine device

Use of Intrauterine device during the follow-up period

Use of combined oral contraceptive during the follow-up period

DRUGProgestin-only pills

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

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

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body Mass Indexfive years follow-upevaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives

Secondary

MeasureTime frameDescription
glycemiafive years follow-upevaluation of variation of glycemia during the usage of hormonal and non-hormonal contraceptives
cholesterol levelfive years follow-upevaluation of variation of cholesterol serum levels during the usage of hormonal and non-hormonal contraceptives
triglycerides levelfive years follow-upevaluation of variation of triglycerides serum levels during the usage of hormonal and non-hormonal contraceptives

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026