A Phase 4 interventional study of Paragard® T380A Intrauterine Copper Contraceptive with New Inserter in Contraception, sponsored by CooperSurgical Inc.. Completed at 8 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by CooperSurgical Inc. · Phase 4, Interventional, and Other
The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.
This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.
CooperSurgical Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential
Combination Product: 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.
Overall Successful Insertions
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.
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Uterine Perforation and IUD Embedment
Frequency of uterine perforation and IUD embedment
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With IUS Expulsions and Dislocations
Frequency of IUS expulsions (partial or total) and dislocations
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Adverse Events
Frequency of Serious Adverse Events (SAE) and Adverse Events (AE)
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Adverse Events Related to Procedure
Frequency of AEs related to procedure
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Vasovagal Events
Frequency of vasovagal events at the time of insertion
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Pelvic Infections
Frequency of pelvic infections related to IUS insertion and use
Time frame: From enrollment to end of treatment at 3 months
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.
| Milestone | Group 1 |
|---|---|
| Started | 117 |
| Completed | 104 |
| Not completed | 13 |
| Withdrew: Adverse event | 8 |
| Withdrew: Physician decision | 1 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| Participants | Group 1 |
|---|---|
| Overall Successful Insertions | 116 (83.8 to 95.2) |
| Overall Unsuccessful Insertions | 1 (69.2 to 100) |
Frequency of uterine perforation and IUD embedment
| Participants | Group 1 |
|---|---|
| Uterine Perforation | 1 |
| IUD Embedment | 1 |
Frequency of IUS expulsions (partial or total) and dislocations
| Participants | Group 1 |
|---|---|
| IUD Expulsion | 3 |
| Dislocation | 2 |
Frequency of Serious Adverse Events (SAE) and Adverse Events (AE)
| Participants | Group 1 |
|---|---|
| Heavy Menstrual Bleeding | 13 |
| Dysmenorrhea | 10 |
| Intermenstrual Bleeding | 4 |
| Abnormal Uterine Bleeding | 3 |
| Vaginal Discharge | 3 |
| Vaginal Hemorrhage | 3 |
| Uterine Spasm | 2 |
Frequency of AEs related to procedure
| Participants | Group 1 |
|---|---|
| Procedural Pain | 2 |
| Procedural Hemorrhage | 1 |
| Procedural Nausea | 1 |
| Uterine Perforation | 1 |
Frequency of vasovagal events at the time of insertion
| Participants | Group 1 |
|---|---|
| Number of Participants With Vasovagal Events | 3 |
Frequency of pelvic infections related to IUS insertion and use
| Participants | Group 1 |
|---|---|
| Number of Participants With Pelvic Infections | 0 |
Collected over Safety evaluations were conducted by study investigators up to 12 weeks post-insertion.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 0/117 (0%) | 2/117 (1.7%) | 44/117 (37.6%) |
| Event | Group 1 |
|---|---|
| Uterine PerforationReproductive system and breast disorders | 1/117 |
| IUS EmbedmentReproductive system and breast disorders | 1/117 |
| Event | Group 1 |
|---|---|
| Heavy Menstrual BleedingReproductive system and breast disorders | 13/117 |
| DysmenorrhoeaReproductive system and breast disorders | 10/117 |
| Muscle SpasmsReproductive system and breast disorders | 5/117 |
| Intermenstrual BleedingReproductive system and breast disorders | 4/117 |
| Abnormal Uterine BleedingReproductive system and breast disorders | 3/117 |
| Vaginal DischargeReproductive system and breast disorders | 3/117 |
| Vaginal HaemorrhageReproductive system and breast disorders | 3/117 |
| Device ExpulsionReproductive system and breast disorders | 3/117 |
| Age, Continuous(Years) | Group 1 |
|---|---|
| Median | 30.0 (18 to 49) |
| Sex: Female, Male(Participants) | Group 1 |
|---|---|
| Female | 117 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Group 1 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 5 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 12 |
| White | 89 |
| More than one race | 2 |
| Unknown or Not Reported | 8 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 |
|---|---|
| Hispanic or Latino | 18 |
| Not Hispanic or Latino | 97 |
| Unknown or Not Reported | 2 |
| Parity(Participants) | Group 1 |
|---|---|
| Parous | 53 |
| Non-Parous | 64 |
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Plan to share: No
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CooperSurgical Inc.