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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01592058

Collaborator

(none)

427

Enrollment

Location

Duration (Months)

18.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Weight Change

Study Design

Study Type:

Observational

Actual Enrollment :

427 participants

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Outcome Measures

Primary Outcome Measures

Weight [Baseline and 12 months]
Change in weight from baseline at 12 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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