Trial Outcomes & Findings for Tracking IUD Bleeding Experiences: An Evaluation of Bleeding Profiles in New Intrauterine Device Users (NCT NCT02311478)

Last Updated: 2025-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

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

Results posted on

2025-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	T380A Copper IUD All participants will receive a T380A copper intrauterine device when enrolled. 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. 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.
Overall Study STARTED	79
Overall Study IUD Insertion	78
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	T380A Copper IUD All participants will receive a T380A copper intrauterine device when enrolled. 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. 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.
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	5
Overall Study Failed IUD Insertion	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	T380A Copper IUD n=78 Participants 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. T380A Intrauterine Copper Contraceptive: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	78 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25.4 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	66 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	7 Participants n=5 Participants
Race/Ethnicity, Customized South Pacific Islander	5 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Region of Enrollment United States	78 Participants n=5 Participants

PRIMARY outcome

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

Population: Healthy Women ages 18-40 with menstrual cycle lengths between 21 and 35 days and menses lasting 3 to 7 days, and completed follow up were eligible for participation and analysis. Women were excluded if they reported use of any hormonal contraception in the previous 3 months.

Outcome measures

Outcome measures
Measure	T380A Copper IUD n=72 Participants 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. T380A Intrauterine Copper Contraceptive: 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.
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. 3 months prior to insertion	4.5 days of bleeding Interval 4.1 to 4.9
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. month 4-month 6	5.5 days of bleeding Interval 5.1 to 5.9
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. month 1-month3	6.0 days of bleeding Interval 5.7 to 6.5

SECONDARY outcome

Timeframe: 6-month post insertion

Determine rates of continuation and level of satisfaction with the IUD during the first 6 months of use.

Outcome measures

Outcome measures
Measure	T380A Copper IUD n=78 Participants 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. T380A Intrauterine Copper Contraceptive: 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.
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. satisfied	51.6 percent of patients
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Method Satisfaction and Continuation at 6 Months Post Insertion. continuing	6.4 percent of patients

SECONDARY outcome

Timeframe: 6 months

% of individuals reporting that their new method had neutral or positive impact of their new contraceptive on their sex life across time points.

Outcome measures

Outcome measures
Measure	T380A Copper IUD n=72 Participants 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. T380A Intrauterine Copper Contraceptive: 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.
Assess the Relationship of Menstrual Cycle Changes Among Women Initiating the Copper T380 IUD to Sexual Functioning and Satisfaction	80 percentage of participants

Adverse Events

T380A Copper IUD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dave Turok

University of Utah

Phone: 8015818160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place