NCT03383185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
489

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
Last Updated

December 26, 2017

Status Verified

December 1, 2017

Enrollment Period

5 years

First QC Date

December 19, 2017

Last Update Submit

December 19, 2017

Conditions

Contraceptive UsageMetabolic SyndromeBody Weight Changes

Keywords

contraceptionBody mass indexMetabolic Syndromeobesity

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index

    evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives

    five years follow-up

Secondary Outcomes (3)

  • glycemia

    five years follow-up

  • cholesterol level

    five years follow-up

  • triglycerides level

    five years follow-up

Study Arms (2)

Non-hormonal contraceptive

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

Device: Intrauterine device

Hormonal contraceptives

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

Drug: Combined Oral ContraceptiveDrug: Progestin-only pillsDrug: Depot-Medroxyprogestereone Acetate

Interventions

Intrauterine deviceDEVICE

Use of Intrauterine device during the follow-up period

Non-hormonal contraceptive
Combined Oral ContraceptiveDRUG

Use of combined oral contraceptive during the follow-up period

Hormonal contraceptives
Progestin-only pillsDRUG

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

Hormonal contraceptives
Depot-Medroxyprogestereone AcetateDRUG

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

Hormonal contraceptives

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
  • use of the same contraceptive method during five years

You may not qualify if:

  • incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo - Unifesp

São Paulo, São Paulo, 0-4023- 062, Brazil

Location

MeSH Terms

Conditions

Contraception BehaviorMetabolic SyndromeBody Weight ChangesObesity

Interventions

Intrauterine DevicesContraceptives, Oral, CombinedMedroxyprogesterone Acetate

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehaviorInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and SuppliesDrug CombinationsPharmaceutical PreparationsContraceptives, OralContraceptive Agents, FemaleContraceptive AgentsReproductive Control AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesTherapeutic UsesMedroxyprogesteroneHydroxyprogesteronesProgesteronePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

December 26, 2017

Record last verified: 2017-12

Locations

BR(1)