Trial Outcomes & Findings for A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive) (NCT NCT05309694)
NCT ID: NCT05309694
Last Updated: 2026-08-25
Results Overview
The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt. A successful insertion includes participants with at least one successful insertion attempt with a maximum of two attempts.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
119 participants
Primary outcome timeframe
From enrollment to end of treatment at 3 months
Results posted on
2026-08-25
Participant Flow
A total of 131 participants were screened, and 119 were enrolled. Of the 119 participants enrolled, 117 underwent up to two placement attempts of the T380A intrauterine copper contraceptive device using the novel inserter.
Participant milestones
| Measure |
Group 1
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
104
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Group 1
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Baseline characteristics by cohort
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Age, Continuous
|
30.0 Years
n=31 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=31 Participants
|
|
Parity
Parous
|
53 Participants
n=31 Participants
|
|
Parity
Non-Parous
|
64 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsThe percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt. A successful insertion includes participants with at least one successful insertion attempt with a maximum of two attempts.
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Overall Successful Insertions
Overall Successful Insertions
|
116 Participants
Interval 83.8 to 95.2
|
|
Overall Successful Insertions
Overall Unsuccessful Insertions
|
1 Participants
Interval 69.2 to 100.0
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsFrequency of uterine perforation and IUD embedment
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Number of Participants With Uterine Perforation and IUD Embedment
Uterine Perforation
|
1 Participants
|
|
Number of Participants With Uterine Perforation and IUD Embedment
IUD Embedment
|
1 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsFrequency of IUS expulsions (partial or total) and dislocations
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Number of Participants With IUS Expulsions and Dislocations
IUD Expulsion
|
3 Participants
|
|
Number of Participants With IUS Expulsions and Dislocations
Dislocation
|
2 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsFrequency of Serious Adverse Events (SAE) and Adverse Events (AE)
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Number of Participants With Adverse Events
Heavy Menstrual Bleeding
|
13 Participants
|
|
Number of Participants With Adverse Events
Dysmenorrhea
|
10 Participants
|
|
Number of Participants With Adverse Events
Intermenstrual Bleeding
|
4 Participants
|
|
Number of Participants With Adverse Events
Abnormal Uterine Bleeding
|
3 Participants
|
|
Number of Participants With Adverse Events
Vaginal Discharge
|
3 Participants
|
|
Number of Participants With Adverse Events
Vaginal Hemorrhage
|
3 Participants
|
|
Number of Participants With Adverse Events
Uterine Spasm
|
2 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsPopulation: Pain, hemorrhage, or nausea at time of insertion that was more severe than typically observed by the investigator.
Frequency of AEs related to procedure
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Number of Participants With Adverse Events Related to Procedure
Procedural Pain
|
2 Participants
|
|
Number of Participants With Adverse Events Related to Procedure
Procedural Hemorrhage
|
1 Participants
|
|
Number of Participants With Adverse Events Related to Procedure
Procedural Nausea
|
1 Participants
|
|
Number of Participants With Adverse Events Related to Procedure
Uterine Perforation
|
1 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsFrequency of vasovagal events at the time of insertion
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Number of Participants With Vasovagal Events
|
3 Participants
|
SECONDARY outcome
Timeframe: From enrollment to end of treatment at 3 monthsFrequency of pelvic infections related to IUS insertion and use
Outcome measures
| Measure |
Group 1
n=117 Participants
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
|
|---|---|
|
Number of Participants With Pelvic Infections
|
0 Participants
|
Adverse Events
Group 1
Serious events: 2 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1
n=117 participants at risk
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
Paragard® T380A Intrauterine Copper Contraceptive with New Inserter: Paragard® IUS with Investigational Inserter combines the current insertion tube and white rod to form a new pre-assembled inserter device that supports a single hand operation.
The device is used to pass the IUS through the cervical canal and into the uterine cavity and facilitates insertion of the T shaped Paragard® IUS implant into the uterus.
|
|---|---|
|
Reproductive system and breast disorders
Uterine Perforation
|
0.85%
1/117 • Number of events 1 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
IUS Embedment
|
0.85%
1/117 • Number of events 1 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
Other adverse events
| Measure |
Group 1
n=117 participants at risk
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
Paragard® T380A Intrauterine Copper Contraceptive with New Inserter: Paragard® IUS with Investigational Inserter combines the current insertion tube and white rod to form a new pre-assembled inserter device that supports a single hand operation.
The device is used to pass the IUS through the cervical canal and into the uterine cavity and facilitates insertion of the T shaped Paragard® IUS implant into the uterus.
|
|---|---|
|
Reproductive system and breast disorders
Heavy Menstrual Bleeding
|
11.1%
13/117 • Number of events 13 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.5%
10/117 • Number of events 10 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Muscle Spasms
|
4.3%
5/117 • Number of events 5 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Intermenstrual Bleeding
|
3.4%
4/117 • Number of events 4 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Abnormal Uterine Bleeding
|
2.6%
3/117 • Number of events 3 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
2.6%
3/117 • Number of events 3 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Vaginal Haemorrhage
|
2.6%
3/117 • Number of events 3 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
|
Reproductive system and breast disorders
Device Expulsion
|
2.6%
3/117 • Number of events 3 • Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.
|
Additional Information
Doug Oberly Sr. Director, Regulatory and Clinical Affairs
CooperSurgical Inc.
Phone: 2036014852
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60