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

Weight Change Clinical Trial

— BMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592058
• Other study ID #: 201102211
• Status: Completed
• Phase: N/A
• First received: May 2, 2012
• Last updated: July 30, 2012
• Start date: June 2010
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 427
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Body Weight
• Body Weight Changes
• Weight Change

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight	Change in weight from baseline at 12 months.	Baseline and 12 months	No

External Links

•   The Contraceptive CHOICE Project website - parent study for BMI