Stress Hormones and IUDs

Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration

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

Study Overview

• Status: Completed
• Conditions: Contraception; Mood Change
• Intervention / Treatment: Device: Mirena; Device: Paraguard

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 Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Study participants will be selected from women's health care clinics in the community.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Women initiating use of an intrauterine device; 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.

Device: Mirena; A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.; Other Names: levonorgestrel intrauterine system; Device: Paraguard; A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.; Other Names: Copper T380A IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in hair cortisol concentration - 6 months	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.	Baseline & 6 months post-insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in hair cortisol concentration - 12 months	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.	Baseline & 12 months post-insertion

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Nora Doty, MD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 13, 2018
• First Posted (Actual): April 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Intrauterine device (IUD); Stress hormones; Mood changes
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: OHSU IRB 18244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No