N/A
N=79
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Intrauterine Devices, Copper · Metrorrhagia · Menstruation · Menstrual Cycle
Bottom Line
View on ClinicalTrials.gov: NCT02311478 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion. — 4.5; 6.0; 5.5 days of bleeding — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- T380A Intrauterine Copper Contraceptive (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Utah
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Changes in Bleeding Duration Among Women Initiating the Copper T380 IUD During the 90 Days Prior to Initiation Compared to Two 90 Periods After IUD Insertion. |
4.5; 6.0; 5.5 | <0.05 sig |
| SECONDARY Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. |
51.6; 6.4 | — |
| SECONDARY Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction |
80 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Use of any hormonal contraceptive method in the previous 3 months
- Irregular duration of menstrual cycles in the last 3 cycles ( 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
Data sourced from ClinicalTrials.gov (NCT02311478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.