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

Completed

• Conditions: Weight Change

• Registration Number: NCT01579773
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 345

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Weight	Baseline and 12 months	Compare changes in body weight and BMI measurements

Secondary Outcome Measures

Name	Time	Method
Body composition	Baseline and 12 months	Compare parameters including fat mass and percentage and central-to-peripheral fat ratios

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States