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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014