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CompletedNCT03383185Updated Dec 26, 2017

Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

An observational study in Contraceptive Usage, Metabolic Syndrome and Body Weight Changes, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-26.

Sponsored by Federal University of São Paulo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
489
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Contraceptive Usage
  • Metabolic Syndrome
  • Body Weight Changes

Keywords

  • contraception
  • Body mass index
  • Metabolic Syndrome
  • obesity
03

In context

Contraception Behavior

132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.

This study's enrollment of 489 is above the median of 149 across 22 observational studies indexed under Contraception Behavior.

Browse Contraception Behavior studies →

Lead sponsor

Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

women in menacme, users of the same contraceptive hormonal (combined oral contraceptives, progestin-only pills and depot-medroxyprodestereone acetate) and non-hormonal contraceptive methods (IUD) during five years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • incomplete data
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
489 participants (actual)
Patient registry
No

Groups and cohorts

  • Non-hormonal contraceptive

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

    Device: Intrauterine device

  • Hormonal contraceptives

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

    Drug: Combined Oral Contraceptive · Drug: Progestin-only pills · Drug: Depot-Medroxyprogestereone Acetate

Interventions

  • DeviceIntrauterine device

    Use of Intrauterine device during the follow-up period

  • DrugCombined Oral Contraceptive

    Drug page: Contraceptives, Oral, Combined

    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

06

What researchers measure

Primary outcomes

  1. 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

  1. glycemia

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

    Time frame: five years follow-up

  2. cholesterol level

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

    Time frame: five years follow-up

  3. triglycerides level

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

    Time frame: five years follow-up

07

Study locations

1 site
  • Federal University of Sao Paulo - Unifesp
    São Paulo, SP 0-4023- 062, Brazil
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03383185
Responsible party
Ana Maria Homem de Mello Bianchi (PhD, Federal University of São Paulo) — Principal investigator
First posted
Dec 26, 2017
Start date
Jan 1, 2010
Primary completion
Jan 1, 2015
Completion
Jan 1, 2015
Last update
Dec 26, 2017

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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