NCT05309694

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: CooperSurgical Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-04
• Primary completion: 2022-12-08
• Completion: 2022-12-08
• First posted: 2022-04-04
• Last updated: 2023-01-20

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study