Stress Hormones and IUDs

Contraception Clinical Trial

Official title:

Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03499379
• Other study ID #: OHSU IRB 18244
• Status: Completed
• Start date: April 16, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: January 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Mood Change

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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