Status:
COMPLETED
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Lead Sponsor:
University of Utah
Conditions:
Intrauterine Devices, Copper
Metrorrhagia
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This study aims to use validated tools as well as new technology to examine changes in bleeding patterns among women who are initiating the copper T380A IUD.
Detailed Description
New users of the intrauterine device (IUD) are most likely to discontinue use within the first six months after insertion. The most common reason for discontinuation of the copper IUD is symptoms rela...
Eligibility Criteria
Inclusion
- Healthy women ages 18-40 years with regular, normal menses (lasting between 3-7 days) and who are initiating an IUD
- Women who can provide bleeding information for 3 cycles off of any hormonal contraception (or non-hormonal IUD) and are willing to track bleeding for 180 days
- Women who are between 6 and 12 months postpartum (if they have had normal menses the last 3 cycles)
Exclusion
- Use of any hormonal contraceptive method in the previous 3 months
- Irregular duration of menstrual cycles in the last 3 cycles (\<21 or \>35 days)
- Recent history of menstrual bleeding lasting less than 3 days or greater than 7 days based on self report of the last 3 cycles
- Contraindication to use of the ParaGard® T380A IUD
- Mucopurulent cervicitis at the time of IUD insertion
- Unable to speak, read, and write in English
- Currently pregnant
- Plans for or desire for pregnancy in the next 6 months
- Currently breastfeeding
- Women who are \<6 months postpartum
- Participation in any clinical investigation utilizing an investigational drug or medical device or requiring invasive gynecologic procedures within the 30 days prior to enrollment
- Wilson's disease
- Known coagulopathy or bleeding disorder
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT02311478
Start Date
December 1 2014
End Date
February 1 2017
Last Update
April 16 2025
Active Locations (1)
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1
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132