## Protocol Section
### Identification Module
**NCT ID:** NCT03499379

**Brief Title:** Stress Hormones and IUDs

**Official Title:** Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration

#### Organization Study ID Info
**ID:** OHSU IRB 18244
#### Organization
**Class:** OTHER
**Full Name:** Oregon Health and Science University
### Status Module
#### Completion Date
**Date:** 2019-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-01-07

**Type:** ACTUAL

**Last Update Submit Date:** 2020-01-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2018-04-16

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2018-04-17
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-09
**Study First Submit QC Date:** 2018-04-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Society of Family Planning

#### Lead Sponsor

**Class:** OTHER

**Name:** Oregon Health and Science University

#### Responsible Party

**Investigator Affiliation:** Oregon Health and Science University

**Investigator Full Name:** Nora Doty, MD

**Investigator Title:** Instructor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Contraception

- Mood Change

**Keywords:**

- Intrauterine device (IUD)

- Depression

- Stress hormones

- Mood changes

### Design Module

#### Bio Spec

**Description:** 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.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 39

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Mirena

- Device: Paraguard

**Label:** Women initiating use of an intrauterine device

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Women initiating use of an intrauterine device

**Description:** 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.

**Name:** Mirena

**Other Names:**

- levonorgestrel intrauterine system

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Women initiating use of an intrauterine device

**Description:** 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.

**Name:** Paraguard

**Other Names:**

- Copper T380A IUD

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Mean change in hair cortisol concentration - 6 months

**Time Frame:** Baseline & 6 months post-insertion

#### Secondary Outcomes

**Description:** 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.

**Measure:** Mean change in hair cortisol concentration - 12 months

**Time Frame:** Baseline & 12 months post-insertion

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 39 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health & Science University

**State:** Oregon

**Zip:** 97239

#### Overall Officials

**Official 1:**

**Affiliation:** Oregon Health and Science University

**Name:** Nora Doty, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000080066

- Term: Contraceptive Agents, Hormonal

- ID: D000003270

- Term: Contraceptive Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000003271

- Term: Contraceptive Agents, Female

- ID: D000003280

- Term: Contraceptives, Oral, Synthetic

- ID: D000003276

- Term: Contraceptives, Oral

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: Mi

- Name: Mineral

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M14244

- Name: Progestins

- Relevance: LOW

- As Found: Unknown

- ID: M9912

- Name: Hydrocortisone

- Relevance: LOW

- As Found: Unknown

- ID: M155245

- Name: Hydrocortisone 17-butyrate 21-propionate

- Relevance: LOW

- As Found: Unknown

- ID: M228609

- Name: Hydrocortisone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M263259

- Name: Hydrocortisone hemisuccinate

- Relevance: LOW

- As Found: Unknown

- ID: M19256

- Name: Levonorgestrel

- Relevance: HIGH

- As Found: SBRT

- ID: M6523

- Name: Copper

- Relevance: LOW

- As Found: Unknown

- ID: M6494

- Name: Contraceptive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M2116

- Name: Contraceptive Agents, Hormonal

- Relevance: LOW

- As Found: Unknown

- ID: M6495

- Name: Contraceptive Agents, Female

- Relevance: LOW

- As Found: Unknown

- ID: M6500

- Name: Contraceptives, Oral

- Relevance: LOW

- As Found: Unknown

- ID: T338

- Name: Copper Supplement

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016912

- Term: Levonorgestrel

### Misc Info Module

- Version Holder: 2024-05-24
