ContraceptionNCT03499379
Stress Hormones and IUDs
An observational study of Contraception and Mood Change, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Determine what kind of side effects women experience in the first year after they start using an intrauterine device. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Mood Change
- What is being tested?
- Mirena and Paraguard
- Type of treatment
- Medical device
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study participants will be selected from women's health care clinics in the community.
Who may be able to join
- Generally healthy
- Age 18-39 years
- Regular menstrual cycles
- Getting an IUD for the purpose of contraception
Who cannot join
- History of mood disorders
- BMI less than 18.5 or greater than 35
- Chronic medical conditions
- Recently pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
Determine what kind of side effects women experience in the first year after they start using an intrauterine device.
Read the 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
- Contraception, Mood Change
- Being tested
- Mirena, Paraguard
- Keywords
- Intrauterine device (IUD), Depression, Stress hormones, Mood changes
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirenaDevice
Also called levonorgestrel intrauterine system
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.
ParaguardDevice
Also called Copper T380A IUD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mirena; Device: Paraguard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline & 6 months post-insertion
Secondary outcomes (1)
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.
Measured: Baseline & 12 months post-insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start16 Apr 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Nora Doty, MD, Oregon Health and Science University
- Investigators
- Nora Doty, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499379
- Sponsor's protocol ID
- OHSU IRB 18244
- Status last verified
- Jan 2020
- First submitted
- 9 Apr 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37633589
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
- ClinicalTrials.gov ID
- NCT03499379
- Acronym / sponsor ID
- OHSU IRB 18244
- Conditions
- Contraception, Mood Change
- Keywords
- Intrauterine device (IUD), Depression, Stress hormones, Mood changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women initiating use of an intrauterine device | – | Device: Mirena, Device: ParaguardWomen 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study participants will be selected from women's health care clinics in the community.
Key inclusion criteria (4 listed)
- Generally healthy
- Age 18-39 years
- Regular menstrual cycles
- Getting an IUD for the purpose of contraception
Key exclusion criteria (4 listed)
- History of mood disorders
- BMI less than 18.5 or greater than 35
- Chronic medical conditions
- Recently pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirenaAlso: levonorgestrel intrauterine systemA 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. | Device | Women initiating use of an intrauterine device |
| ParaguardAlso: Copper T380A IUDA 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. | Device | Women initiating use of an intrauterine device |
Primary outcome
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.
1 secondary outcome
Mean change in hair cortisol concentration - 12 months
Time frame: Baseline & 12 months post-insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 37633589Doty 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nora Doty, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Mood Change, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in hair cortisol concentration - 6 months (time frame: Baseline & 6 months post-insertion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.