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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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Determine what kind of side effects women experience in the first year after they start using an intrauterine device.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Study participants will be selected from women's health care clinics in the community.
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| Name | Affiliation | Role |
|---|---|---|
| Nora Doty, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37633589 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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| 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. |
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