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Completed

NCT Number: NCT03383185

Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

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

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Key information

Conditions

Contraceptive Usage Behavior Body Weight Body Weight Changes Contraception Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Reproductive Behavior Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Federal University of Sao Paulo - Unifesp

São Paulo, 0-4023- 062, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Body Mass Index

    Time frame: five years follow-up

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

Secondary outcomes

  1. glycemia

    Time frame: five years follow-up

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

  2. cholesterol level

    Time frame: five years follow-up

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

  3. triglycerides level

    Time frame: five years follow-up

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Dec 26, 2017
Registry last updated
Dec 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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