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

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.

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Key information

Conditions

Weight Change Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

The study has finished enrolling new participants.

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

Treatment and study plan

Primary outcomes

Weight

Time frame: Baseline and 12 months

Compare changes in body weight and BMI measurements

Secondary outcomes

Body composition

Time frame: Baseline and 12 months

Compare parameters including fat mass and percentage and central-to-peripheral fat ratios

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: DEXA

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Apr 18, 2012
Registry last updated: Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed