Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

Completed

• Conditions: Contraceptive Usage; Metabolic Syndrome; Body Weight Changes
• Interventions: Drug: Combined Oral Contraceptive; Device: Intrauterine device; Drug: Progestin-only pills; Drug: Depot-Medroxyprogestereone Acetate

• Registration Number: NCT03383185
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2015-01-01
• Study Completion: 2015-01-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Last Update Submitted: 2017-12-19
• Study First Posted: 2017-12-26
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 489

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hormonal contraceptives	Combined Oral Contraceptive	Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up
Hormonal contraceptives	Progestin-only pills	Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up
Non-hormonal contraceptive	Intrauterine device	Users of non- hormonal intrauterine device during the 5 years follow-up
Hormonal contraceptives	Depot-Medroxyprogestereone Acetate	Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up

Primary Outcome Measures

Name	Time	Method
Body Mass Index	five years follow-up	evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Federal University of Sao Paulo - Unifesp; 🇧🇷 São Paulo, SP, Brazil