Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users

NCT02311478 | Completed Results

• 1 other identifier: 75363
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Devices, Copper; Metrorrhagia; Menstruation; Menstrual Cycle

Outcome Measures

Primary Outcomes (1)

• 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.

  Evaluate bleeding duration among women initiating the copper T380 IUD during the 90 days prior to initiation compared to two 90 periods after IUD insertion. Women will track bleeding after the insertion of the T380A IUD for 180 days. Participants will be contacted monthly to collect data.

  3 months prior to insertion, month 1-month 3 , month 4-month 6

Secondary Outcomes (2)

• Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion.

  6-month post insertion

• Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction

  6 months

Study Arms (1)

T380A Copper IUD

EXPERIMENTAL

All participants will receive a T380A copper intrauterine device when enrolled. They can continue using the device for as long as they wish. The study will be completed when 6 months of prospective bleeding data has been collected.

Device: T380A Intrauterine Copper Contraceptive

Interventions

T380A Intrauterine Copper Contraceptive DEVICE

The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus.

Also known as: Paragard

T380A Copper IUD

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations • Baseline bleeding collected retrospectively Strengths: * Prospective follow-up with 90% completion * Uses validated bleeding measures \& electronic period trackers to improve reporting accuracy

Results Point of Contact

• Title: Dr. Dave Turok
• Organization: University of Utah

david.turok@hsc.utah.edu

8015818160

Study Officials

• David Turok, MD

  Unviersity of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 8, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 16, 2025
• Results First Posted: July 30, 2019

Record last verified: 2025-04

Locations

US (1)