A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Contraception

Intervention / Treatment
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* Combination Product: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm and open-label design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From enrollment to end of treatment at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uterine Perforation and IUD Embedment | Frequency of uterine perforation and IUD embedment | From enrollment to end of treatment at 3 months | 
| IUS Expulsions and Dislocations | Frequency of IUS expulsions (partial or total) and dislocations | From enrollment to end of treatment at 3 months | 
| Adverse Events | Frequency of Serious Adverse Events (SAE) and Adverse Events (AE) | From enrollment to end of treatment at 3 months | 
| Adverse Events related to Procedure | Frequency of AEs related to procedure | From enrollment to end of treatment at 3 months | 
| Vasovagal Events | Frequency of vasovagal events at the time of insertion | From enrollment to end of treatment at 3 months | 
| Pelvic Infections | Frequency of pelvic infections related to IUS insertion and use | From enrollment to end of treatment at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Copper Intrauterine Device, Intrauterine Device, Contraceptive, Birth Control, IUD, IUS, Intrauterine System