Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03383185
• Other study ID #: CAAE: 45523715.4.0000.5505
• Status: Completed
• Phase: N/A
• First received: December 19, 2017
• Last updated: December 19, 2017
• Start date: January 1, 2010
• Est. completion date: January 1, 2015

Study information

• Verified date: December 2017
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: January 1, 2015
• Est. primary completion date: January 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Contraceptive Usage
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Device:
• Intrauterine device
Use of Intrauterine device during the follow-up period

Drug:
• Combined Oral Contraceptive
Use of combined oral contraceptive during the follow-up period
• Progestin-only pills
Use of progestin-only pills during the follow-up period
• Depot-Medroxyprogestereone Acetate
Use of depot-medroxyprogesterone acetato during the follow-up period

Locations

Country	Name	City	State
Brazil	Federal University of Sao Paulo - Unifesp	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index	evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives	five years follow-up
Secondary	glycemia	evaluation of variation of glycemia during the usage of hormonal and non-hormonal contraceptives	five years follow-up
Secondary	cholesterol level	evaluation of variation of cholesterol serum levels during the usage of hormonal and non-hormonal contraceptives	five years follow-up
Secondary	triglycerides level	evaluation of variation of triglycerides serum levels during the usage of hormonal and non-hormonal contraceptives	five years follow-up