Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

Sponsor

Federal University of São Paulo (Other)

Overall Status

Completed

CT.gov ID

NCT03383185

Collaborator

(none)

489

Enrollment

Location

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Contraceptive Usage Metabolic Syndrome Body Weight Changes	Device: Intrauterine device Drug: Combined Oral Contraceptive Drug: Progestin-only pills Drug: Depot-Medroxyprogestereone Acetate

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 Design

Study Type:

Observational

Actual Enrollment :

489 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Non-hormonal contraceptive Users of non- hormonal intrauterine device during the 5 years follow-up	Device: Intrauterine device Use of Intrauterine device during the follow-up period
Hormonal contraceptives Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up	Drug: Combined Oral Contraceptive Use of combined oral contraceptive during the follow-up period Drug: Progestin-only pills Use of progestin-only pills during the follow-up period Drug: Depot-Medroxyprogestereone Acetate Use of depot-medroxyprogesterone acetato during the follow-up period

Arm

Intervention/Treatment

Non-hormonal contraceptive

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

Device: Intrauterine device

Use of Intrauterine device during the follow-up period

Hormonal contraceptives

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

Drug: Combined Oral Contraceptive

Use of combined oral contraceptive during the follow-up period

Drug: Progestin-only pills

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

Drug: Depot-Medroxyprogestereone Acetate

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

Outcome Measures

Primary Outcome Measures

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

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