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Stress Hormones and IUDs

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ClinicalTrials.gov Identifier: NCT03499379
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 31, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Nora Doty, Oregon Health and Science University

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

Condition or disease
Contraception Mood Change

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.

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Study Type : Observational
Estimated Enrollment : 86 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control




Primary Outcome Measures :
  1. Mean change in hair cortisol concentration - 6 months [ Time Frame: 6 months from baseline ]
    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.


Secondary Outcome Measures :
  1. Mean change in hair cortisol concentration - 12 months [ Time Frame: 12 months from baseline ]
    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.


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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be selected from women's health care clinics in the community.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499379


Contacts
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Contact: Women's Health Research Unit Confidential Recruitment Line 503-494-3666 whru@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Women's Health Research Unit Confidential Recruitment Line    503-494-3666    whru@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
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Principal Investigator: Nora Doty, MD Oregon Health and Science University

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Responsible Party: Nora Doty, Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03499379     History of Changes
Other Study ID Numbers: OHSU IRB 18244
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nora Doty, Oregon Health and Science University:
Intrauterine device (IUD)
Depression
Stress hormones
Mood changes