Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period (BMI)

The purpose of this study is to learn whether women who use progestin-only methods of birth control such as the contraceptive implant (Implanon), the levonorgestral-releasing IUS (Mirena), or depot medroxyprogesterone acetate(DMPA) will experience weight change compared to women using the non-hormonal copper IUC (ParaGard).

The investigators primary hypothesis is that users of DMPA will gain excess weight and increase their BMI above the copper-IUC users; secondarily, the investigators will compare users' data in the LNG-IUC and ENG implant groups to the copper-IUC group.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

427

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Participants already enrolled in the Contraceptive CHOICE Project will be offered participation during their 12-month follow up window if they had originally selected one of the four methods being studied during CHOICE enrollment.

Description

Inclusion Criteria:

  • Patients enrolled in CHOICE between the ages of 18 and 45 who consented to future studies
  • Chose levonorgestrel-releasing IUD, copper IUD, the implant, or DMPA as their CHOICE baseline method
  • Has baseline height and weight data collected from the on-campus enrollment site
  • Able to come back to the on-campus enrollment site for consent process and enrollment activities

Exclusion Criteria:

  • Recent history of DMPA use before starting their baseline CHOICE method
  • Used current method for less than 11 months or more than 12 months and three weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline and 12 months
Change in weight from baseline at 12 months.
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 4, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Weight Change

3
Subscribe