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Comparison of Body Composition & Weight Change in Users of Progestin-only Contraception During the First Year of Use

NCT ID: NCT01579773

Last Updated: 2014-12-10

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

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-08-31

Brief Summary

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The purpose of this study is to learn if women gain weight using progestin-only methods of contraception and if so, how much. The investigators will look at users of two progestin-only methods: the levonorgestrel-containing intrauterine contraceptive (LNG-IUC) and the etonorgestrel (ENG) subdermal implant, and compare these users' weight change to that of users of a non-hormonal method, the copper intrauterine device.

The primary hypothesis is that ENG implant and LNG-IUC users' weight and body composition will increase more than the copper-IUD users. The investigators will collect body composition data using dual-energy x-ray absorptiometry (DEXA), and collect information about diet and activity using validated questionnaires.

Detailed Description

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Conditions

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Weight Change

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participants between the ages of 18 and 45 years
* Participants starting the copper IUD or implant through their provider
* First study visit must occur within 14 days of method insertion

Exclusion Criteria

* DMPA in the past 16 weeks
* POPs, LNG-IUC, or the implant in the past 4 weeks
* Thyroid disease
* Autoimmune disease
* Diabetes (excluding gestational)
* History of eating disorder
* Currently taking antidepressants for \< 6 months
* Currently taking antipsychotics
* Currently taking oral glucocorticoids (steroids, i.e. prednisone) for more than 6 months
* Currently breastfeeding
* Less than 6 months post-partum
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

Other Identifiers

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80158

Identifier Type: -

Identifier Source: org_study_id