N/A
Completed N=79
Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users
Intrauterine Devices, Copper · Metrorrhagia · Menstruation · Menstrual Cycle
Source: ClinicalTrials.gov NCT02311478 ↗
Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.