Stress Hormones and IUDs

Oregon Health & Science University (OHSU)

Status: Completed

Conditions: Contraception; Mood Change

Treatments: Device: Mirena; Device: Paraguard

Study type: Observational

Funder types: Other

Identifiers

NCT03499379

OHSU IRB 18244

Details and patient eligibility

About

Determine what kind of side effects women experience in the first year after they start using an intrauterine device.

Full description

The purpose of this study is to find out if there is a difference in levels of stress hormones in women who use copper or hormonal intrauterine devices (IUDs). This study will provide more information on the potential effect of levonorgestrel intrauterine system (LNG-IUS) use on an individual's stress response. Ultimately, this study hopes to provide data to better counsel women on potential mood effects of the LNG-IUS. From a research and clinical management perspective, hair cortisol may provide a tool to evaluate women at risk for discontinuation of hormonal contraception due to concern of mood symptoms.

Enrollment: 39 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Generally healthy
• Age 18-39 years
• Regular menstrual cycles
• Getting an IUD for the purpose of contraception

Exclusion criteria

• History of mood disorders
• BMI less than 18.5 or greater than 35
• Chronic medical conditions
• Recently pregnant or lactating

Trial design

39 participants in 1 patient group

Women initiating use of an intrauterine device

Description:

Women obtaining a copper or hormonal intrauterine device for the purpose of contraception. A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex will be taken at the time of IUD insertion, 6 months post-insertion, and 12 months post-insertion.

Treatment:

Device: Paraguard

Device: Mirena