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OpenTrials
Completed

NCT Number: NCT01592058

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

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.

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Key information

Conditions

Weight Change Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Weight

    Time frame: Baseline and 12 months

    Change in weight from baseline at 12 months.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: BMI

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 4, 2012
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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