NCT03499379

Stress Hormones and IUDs

Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 39 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Contraception
• Mood Change

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-04-16
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-04-17
• Last updated: 2020-01-07

Locations

1 site across 1 country: United States