Contraceptive UsageNCT03383185
Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives
An observational study of Contraceptive Usage and Metabolic Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Evaluation of metabolic profile of users of hormonal and non-hormonal contraceptives during five years follow-up Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraceptive Usage, Metabolic Syndrome, Body Weight Changes
- What is being tested?
- Intrauterine device, Combined Oral Contraceptive and Progestin-only pills
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 489 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2010to 1 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
- use of the same contraceptive method during five years
Who cannot join
- incomplete data
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Unifesp
São Paulo, São Paulo, 0-4023- 062
About this study
Official title: 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
Read the 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.
- Conditions
- Contraceptive Usage, Metabolic Syndrome, Body Weight Changes
- Being tested
- Intrauterine device, Combined Oral Contraceptive, Progestin-only pills, Depot-Medroxyprogestereone Acetate
- Keywords
- contraception, Body mass index, Metabolic Syndrome, obesity
- Medical subject headings
- Contraception Behavior, Metabolic Syndrome, Body Weight Changes, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine deviceDevice
Use of Intrauterine device during the follow-up period
Combined Oral ContraceptiveDrug
Use of combined oral contraceptive during the follow-up period
Progestin-only pillsDrug
Use of progestin-only pills during the follow-up period
Depot-Medroxyprogestereone AcetateDrug
Use of depot-medroxyprogesterone acetato during the follow-up period
| Study group | Role | What they receive |
|---|---|---|
| Non-hormonal contraceptive | Users of non- hormonal intrauterine device during the 5 years follow-up Receives: Device: Intrauterine device | |
| Hormonal contraceptives | Users of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up Receives: Drug: Combined Oral Contraceptive; Drug: Progestin-only pills; Drug: Depot-Medroxyprogestereone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives
Measured: five years follow-up
Secondary outcomes (3)
glycemia
evaluation of variation of glycemia during the usage of hormonal and non-hormonal contraceptives
Measured: five years follow-up
cholesterol level
evaluation of variation of cholesterol serum levels during the usage of hormonal and non-hormonal contraceptives
Measured: five years follow-up
triglycerides level
evaluation of variation of triglycerides serum levels during the usage of hormonal and non-hormonal contraceptives
Measured: five years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2010
- Primary completion1 Jan 2015
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maria Homem de Mello Bianchi, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383185
- Sponsor's protocol ID
- CAAE: 45523715.4.0000.5505
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives, 5-year Follow-up
- ClinicalTrials.gov ID
- NCT03383185
- Acronym / sponsor ID
- CAAE: 45523715.4.0000.5505
- Conditions
- Contraceptive Usage, Metabolic Syndrome, Body Weight Changes
- Keywords
- contraception, Body mass index, Metabolic Syndrome, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-hormonal contraceptive | – | Device: Intrauterine deviceUsers of non- hormonal intrauterine device during the 5 years follow-up |
| Hormonal contraceptives | – | Drug: Combined Oral Contraceptive, Drug: Progestin-only pills, Drug: Depot-Medroxyprogestereone AcetateUsers of combined oral contraceptive, progestin-only pills, depot-medroxyprogestereone acetate during 5 years follow-up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- women in reproductive age followed in Federal university of Sao Paulo Family Planning Service
- use of the same contraceptive method during five years
Key exclusion criteria (1 listed)
- incomplete data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrauterine deviceUse of Intrauterine device during the follow-up period | Device | Non-hormonal contraceptive |
| Combined Oral ContraceptiveUse of combined oral contraceptive during the follow-up period | Drug | Hormonal contraceptives |
| Progestin-only pillsUse of progestin-only pills during the follow-up period | Drug | Hormonal contraceptives |
| Depot-Medroxyprogestereone AcetateUse of depot-medroxyprogesterone acetato during the follow-up period | Drug | Hormonal contraceptives |
Primary outcome
Body Mass Index
Time frame: five years follow-up
evaluation of variation of body mass index during the usage of hormonal and non-hormonal contraceptives
3 secondary outcomes
glycemia
Time frame: five years follow-up
cholesterol level
Time frame: five years follow-up
triglycerides level
Time frame: five years follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraceptive Usage and Metabolic Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: five years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.