Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

Study Overview
=================
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.

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

Conditions
-----------------
Contraceptive Usage, Metabolic Syndrome, Body Weight Changes

Intervention / Treatment
-----------------
* Device: Intrauterine device
* Drug: Combined Oral Contraceptive
* Drug: Progestin-only pills
* Drug: Depot-Medroxyprogestereone Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives | five years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemia | evaluation of variation of glycemia during the usage of hormonal and non-hormonal contraceptives | five years follow-up | 
| cholesterol level | evaluation of variation of cholesterol serum levels during the usage of hormonal and non-hormonal contraceptives | five years follow-up | 
| triglycerides level | evaluation of variation of triglycerides serum levels during the usage of hormonal and non-hormonal contraceptives | five years follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
contraception, Body mass index, Metabolic Syndrome, obesity