Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives

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

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

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome; Body Weight Changes; Contraceptive Usage
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 489

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 0-4023- 062
      • Federal University of Sao Paulo - Unifesp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women in menacme, users of the same contraceptive hormonal (combined oral contraceptives, progestin-only pills and depot-medroxyprodestereone acetate) and non-hormonal contraceptive methods (IUD) during five years

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 19, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: obesity; Metabolic Syndrome; contraception; Body mass index
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome; Body Weight; Body Weight Changes; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Contraceptives, Oral, Hormonal; Contraceptive Agents, Male; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Progestins; Medroxyprogesterone Acetate; Medroxyprogesterone
• Other Study ID Numbers: CAAE: 45523715.4.0000.5505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No