Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period

NCT ID: NCT01592058

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

427 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to learn whether women who use progestin-only methods of birth control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared to women using the non-hormonal copper IUC (ParaGard).

The investigators primary hypothesis is that users of DMPA will gain excess weight and increase their BMI above the copper-IUC users; secondarily, the investigators will compare users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.

Detailed Description

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Conditions

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Weight Change

Keywords

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weight change contraception birth control progestin progestin only weight gain depo Depo Provera DMPA IUD IUC Mirena Paragard Implanon implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients enrolled in CHOICE between the ages of 18 and 45 who consented to future studies
* Chose levonorgestrel-releasing IUD, copper IUD, the implant, or DMPA as their CHOICE baseline method
* Has baseline height and weight data collected from the on-campus enrollment site
* Able to come back to the on-campus enrollment site for consent process and enrollment activities

Exclusion Criteria

* Recent history of DMPA use before starting their baseline CHOICE method
* Used current method for less than 11 months or more than 12 months and three weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tessa E Madden, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.choiceproject.wustl.edu/

The Contraceptive CHOICE Project website - parent study for BMI

Other Identifiers

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201102211

Identifier Type: -

Identifier Source: org_study_id