Stress Hormones and IUDs

NCT03499379 | Completed

• 1 other identifier: OHSU IRB 18244
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contraception; Mood Change

Keywords

Intrauterine device (IUD); Depression; Stress hormones; Mood changes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean change in hair cortisol concentration - 12 months

  Baseline & 12 months post-insertion

Study Arms (1)

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; Device: Paraguard

Interventions

Mirena DEVICE

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.

Also known as: levonorgestrel intrauterine system

Women initiating use of an intrauterine device

Paraguard DEVICE

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.

Also known as: Copper T380A IUD

Women initiating use of an intrauterine device

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Doty N, Beckley E, Garg B, Maristany S, Erikson DW, Jensen JT. Changes in hair cortisol concentration in intrauterine device initiators: A prospective cohort study. Contraception. 2023 Dec;128:110142. doi: 10.1016/j.contraception.2023.110142. Epub 2023 Aug 24.

  PMID: 37633589 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex. Whole blood samples collected at each study visit (approximately 10mL). The serum from those samples will tested for hormone levels.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Nora Doty, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: April 16, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)