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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03499379|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : May 31, 2018
|Condition or disease|
|Contraception Mood Change|
|Study Type :||Observational|
|Estimated Enrollment :||86 participants|
|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|
- 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.
- 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.
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
|Contact: Women's Health Research Unit Confidential Recruitment Linefirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Nora Doty, MD||Oregon Health and Science University|