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Stress Hormones and IUDs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03499379
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Nora Doty, MD, Oregon Health and Science University

Tracking Information
First Submitted Date April 9, 2018
First Posted Date April 17, 2018
Last Update Posted Date January 7, 2020
Actual Study Start Date April 16, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2019)
Mean change in hair cortisol concentration - 6 months [ Time Frame: Baseline & 6 months post-insertion ]
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.
Original Primary Outcome Measures
 (submitted: April 13, 2018)
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.
Change History
Current Secondary Outcome Measures
 (submitted: November 13, 2019)
Mean change in hair cortisol concentration - 12 months [ Time Frame: Baseline & 12 months post-insertion ]
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.
Original Secondary Outcome Measures
 (submitted: April 13, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Stress Hormones and IUDs
Official Title Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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.

Sampling Method Non-Probability Sample
Study Population Study participants will be selected from women's health care clinics in the community.
Condition
  • Contraception
  • Mood Change
Intervention
  • 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.
    Other Name: levonorgestrel intrauterine system
  • 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.
    Other Name: Copper T380A IUD
Study Groups/Cohorts 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.

Interventions:
  • Device: Mirena
  • Device: Paraguard
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 10, 2019)
39
Original Estimated Enrollment
 (submitted: April 13, 2018)
86
Actual Study Completion Date December 31, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03499379
Other Study ID Numbers OHSU IRB 18244
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nora Doty, MD, Oregon Health and Science University
Study Sponsor Oregon Health and Science University
Collaborators Society of Family Planning
Investigators
Principal Investigator: Nora Doty, MD Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date January 2020