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

Weight Change Clinical Trial

— DEXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579773
• Other study ID #: 80158
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: December 8, 2014
• Start date: April 2010
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Body Weight Changes
• Weight Change

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Compare changes in body weight and BMI measurements	Baseline and 12 months	No
Secondary	Body composition	Compare parameters including fat mass and percentage and central-to-peripheral fat ratios	Baseline and 12 months	No