ContraceptionPhase 4NCT05309694
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
A Phase 4 study testing Paragard® T380A Intrauterine Copper Contraceptive with New Inserter in people with Contraception, run by CooperSurgical Inc. at 8 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Paragard® T380A Intrauterine Copper Contraceptive with New Inserter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Mar 2022to 8 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is a postmenarcheal and premenopausal woman of child bearing potential.
- Subjects are at least 18 years of age, at the time of signing the informed consent.
- Subject is overtly healthy as determined by medical evaluation.
Who cannot join
- Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
- History of previous IUD complications
- Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
- Known anatomical abnormalities of the cervix
- Presence of acute pelvic inflammatory disease at the time of screening.
- Postpartum endometritis.
Show all 11Show fewer
- Known or suspected uterine or cervical malignancy.
- Uterine bleeding of unknown etiology.
- Untreated acute cervicitis or vaginitis or other lower genital tract infection.
- Conditions associated with increased susceptibility to pelvic infections.
- Subjects with Wilson's disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
GYN-CARE Women's Healthcare
Atlanta, Georgia, 30363
Central Austin - Women Partners in Health
Austin, Texas, 78705
Austin Area Ob-Gyn & Fertility
Austin, Texas, 78758
Downtown Women's Healthcare
Denver, Colorado, 80218
Hilltop Obstetrics & Gynecology
Franklin, Ohio, 45005
Valley Ob-Gyn Clinic, PC
Saginaw, Michigan, 48602
Seattle Clinical Research Center
Seattle, Washington, 98105
South Miami Women's Health
South Miami, Florida, 33143
About this study
Official title: A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive
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.
Read the detailed description
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.
- Conditions
- Contraception
- Being tested
- Paragard® T380A Intrauterine Copper Contraceptive with New Inserter
- Keywords
- Contraception, Copper Intrauterine Device, Intrauterine Device, Contraceptive, Birth Control, IUD, IUS, Intrauterine System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paragard® T380A Intrauterine Copper Contraceptive with New InserterCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential Receives: Combination Product: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment at 3 months
Secondary outcomes (6)
Number of Participants With Uterine Perforation and IUD Embedment
Frequency of uterine perforation and IUD embedment
Measured: 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
Measured: 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)
Measured: From enrollment to end of treatment at 3 months
Number of Participants With Adverse Events Related to Procedure
Frequency of AEs related to procedure
Measured: From enrollment to end of treatment at 3 months
Number of Participants With Vasovagal Events
Frequency of vasovagal events at the time of insertion
Measured: 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
Measured: From enrollment to end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start4 Mar 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm and open-label design
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperSurgical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robin Kroll, MD, Principal investigator, Seattle Clinical Research CenterCarol Stamm, MD, Principal investigator, Downtown Women's HealthcareJoyce Miller, MD, Principal investigator, South Miami Women's HealthJacquelyn Robinson, MD, Principal investigator, Valley Ob-Gyn Clinic, PCRonald Hirth, MD, Principal investigator, Hilltop Obstetrics & GynecologyMark Akin, MD, Principal investigator, Austin Area Ob-Gyn & FertilityStephanie Reich, MD, Principal investigator, Central Austin - Women Partners in HealthEric L Brown, MD, Principal investigator, GYN-CARE Women's Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309694
- Sponsor's protocol ID
- CSIPD-001
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2022
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dunsmoor-Su RF, Desai VB, Pandolfi EC, Audette CR, Miller JR, Fuller AE, Brown EL, Hirth RD, Seetal-Kihei KV, McKain LF. Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter. O G Open. 2025 Mar 6;2(2):e068. doi: 10.1097/og9.0000000000000068. eCollection 2025 Apr.
PubMed 41000288
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive
- ClinicalTrials.gov ID
- NCT05309694
- Acronym / sponsor ID
- CSIPD-001
- Conditions
- Contraception
- Keywords
- Contraception, Copper Intrauterine Device, Intrauterine Device, Contraceptive, Birth Control, IUD, IUS, Intrauterine System
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- CooperSurgical Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm and open-label design
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Combination Product: Paragard® T380A Intrauterine Copper Contraceptive with New InserterParagard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is a postmenarcheal and premenopausal woman of child bearing potential.
- Subjects are at least 18 years of age, at the time of signing the informed consent.
- Subject is overtly healthy as determined by medical evaluation.
Key exclusion criteria (11 listed)
- Pregnancy or suspicion of pregnancy or at risk for luteal phase pregnancy
- History of previous IUD complications
- Abnormalities of the uterus resulting in distortion of the uterine cavity that may complicate IUD insertion
- Known anatomical abnormalities of the cervix
- Presence of acute pelvic inflammatory disease at the time of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paragard® T380A Intrauterine Copper Contraceptive with New InserterParagard® 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. | Combination product | Group 1 |
Primary outcome
Overall Successful Insertions
Time frame: From enrollment to end of treatment at 3 months
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.
6 secondary outcomes
Number of Participants With Uterine Perforation and IUD Embedment
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With IUS Expulsions and Dislocations
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Adverse Events
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Adverse Events Related to Procedure
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Vasovagal Events
Time frame: From enrollment to end of treatment at 3 months
Number of Participants With Pelvic Infections
Time frame: From enrollment to end of treatment at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41000288Dunsmoor-Su RF, Desai VB, Pandolfi EC, Audette CR, Miller JR, Fuller AE, Brown EL, Hirth RD, Seetal-Kihei KV, McKain LF. Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter. O G Open. 2025 Mar 6;2(2):e068. doi: 10.1097/og9.0000000000000068. eCollection 2025 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Kroll, MD principal investigator
Seattle Clinical Research Center
Carol Stamm, MD principal investigator
Downtown Women's Healthcare
Joyce Miller, MD principal investigator
South Miami Women's Health
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paragard® T380A Intrauterine Copper Contraceptive with New Inserter in people with Contraception, run by CooperSurgical Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Successful Insertions (time frame: From enrollment to end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.