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Completed

NCT Number: NCT05309694

A Study to Assess the Safety of a New Inserter Device for Paragard® (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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Downtown Women's Healthcare, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paragard® T380A Intrauterine Copper Contraceptive with New Inserter

Combination 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Uterine Perforation and IUD Embedment

    Time frame: From enrollment to end of treatment at 3 months

    Frequency of uterine perforation and IUD embedment

  2. IUS Expulsions and Dislocations

    Time frame: From enrollment to end of treatment at 3 months

    Frequency of IUS expulsions (partial or total) and dislocations

  3. Adverse Events

    Time frame: From enrollment to end of treatment at 3 months

    Frequency of Serious Adverse Events (SAE) and Adverse Events (AE)

  4. Adverse Events related to Procedure

    Time frame: From enrollment to end of treatment at 3 months

    Frequency of AEs related to procedure

  5. Vasovagal Events

    Time frame: From enrollment to end of treatment at 3 months

    Frequency of vasovagal events at the time of insertion

  6. Pelvic Infections

    Time frame: From enrollment to end of treatment at 3 months

    Frequency of pelvic infections related to IUS insertion and use

Sponsors and collaborators

Lead sponsor

CooperSurgical Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 4, 2022
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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