Stress Hormones and IUDs

Completed

• Conditions: Mood Change; Contraception
• Interventions: Device: Mirena; Device: Paraguard

• Registration Number: NCT03499379
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-04-09
• Study First Submitted QC: 2018-04-13
• Study Start: 2018-04-16
• Study First Posted: 2018-04-17
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-03
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women initiating use of an intrauterine device	Paraguard	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.
Women initiating use of an intrauterine device	Mirena	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.

Primary Outcome Measures

Name	Time	Method
Mean change in hair cortisol concentration - 6 months	Baseline & 6 months post-insertion	A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 6 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 6 months.

Secondary Outcome Measures

Name	Time	Method
Mean change in hair cortisol concentration - 12 months	Baseline & 12 months post-insertion	A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 12 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 12 months.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States