NCT01579773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

4.3 years

First QC Date

April 10, 2012

Last Update Submit

December 8, 2014

Conditions

Weight Change

Outcome Measures

Primary Outcomes (1)

  • Weight

    Compare changes in body weight and BMI measurements

    Baseline and 12 months

Secondary Outcomes (1)

  • Body composition

    Baseline and 12 months

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants who are starting an IUD or implant through their provider could be eligible.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tessa E Madden, MD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 18, 2012

Study Start

April 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)