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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01592058
First received: May 2, 2012
Last updated: July 30, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition
Weight Change

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Weight Change Among Users of Three Progestin-Only Methods of Contraception Over a 12-Month Time Period

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Weight [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
    Change in weight from baseline at 12 months.


Enrollment: 427
Study Start Date: June 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01592058

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Tessa E Madden, MD, MPH Washington University School of Medicine
  More Information

Additional Information:
The Contraceptive CHOICE Project website - parent study for BMI  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01592058     History of Changes
Other Study ID Numbers: 201102211
Study First Received: May 2, 2012
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
weight change
contraception
birth control
progestin
progestin only
weight gain
depo
Depo Provera
 DMPA
IUD
IUC
Mirena
Paragard
Implanon
implant

Additional relevant MeSH terms:
Body Weight Changes
Body Weight
Signs and Symptoms
Progestins
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013