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Can a redesigned IUD inserter make birth control safer and easier?

NCT ID NCT05309694

Disease control Sponsor: CooperSurgical Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study tests a newly designed inserter for the Paragard T380A intrauterine copper contraceptive, a long-acting birth control device. The goal is to see if the new inserter allows for successful and safe placement of the IUD in women of reproductive age. Researchers will track how often insertions are successful, as well as any complications like uterine perforation, embedment, or expulsion. The study aims to confirm that the new inserter works as well as the currently approved version.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paragard T380A intrauterine copper contraceptive with a new inserter device
What this could lead to
If successful, this could confirm that the new inserter is as safe and effective as the current one, potentially improving the insertion experience for women choosing this birth control method.
What could go wrong
This is a post-marketing study with a relatively small number of participants, so rare complications might not be fully captured. The new inserter could still have unforeseen issues, such as a higher risk of perforation or expulsion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

119 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contraception

Contacts and locations

Locations

  • Austin Area Ob-Gyn & Fertility

    Austin, Texas, 78758, United States

  • Central Austin - Women Partners in Health

    Austin, Texas, 78705, United States

  • Downtown Women's Healthcare

    Denver, Colorado, 80218, United States

  • GYN-CARE Women's Healthcare

    Atlanta, Georgia, 30363, United States

  • Hilltop Obstetrics & Gynecology

    Franklin, Ohio, 45005, United States

  • Seattle Clinical Research Center

    Seattle, Washington, 98105, United States

  • South Miami Women's Health

    South Miami, Florida, 33143, United States

  • Valley Ob-Gyn Clinic, PC

    Saginaw, Michigan, 48602, United States

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