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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01579773

Acronym

DEXA

Enrollment

345

Registered

2012-04-18

Start date

2010-04-30

Completion date

2014-08-31

Last updated

2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight Change

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Weight	Baseline and 12 months	Compare changes in body weight and BMI measurements

Secondary

Measure	Time frame	Description
Body composition	Baseline and 12 months	Compare parameters including fat mass and percentage and central-to-peripheral fat ratios

Countries

United States

Outcome results