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

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05309694
• Other study ID #: CSIPD-001
• Status: Completed
• Phase: Phase 4
• Start date: March 4, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: January 2023
• Source: CooperSurgical Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
United States	GYN-CARE Women's Healthcare	Atlanta	Georgia
United States	Austin Area Ob-Gyn & Fertility	Austin	Texas
United States	Central Austin - Women Partners in Health	Austin	Texas
United States	Downtown Women's Healthcare	Denver	Colorado
United States	Hilltop Obstetrics & Gynecology	Franklin	Ohio
United States	Valley Ob-Gyn Clinic, PC	Saginaw	Michigan
United States	Seattle Clinical Research Center	Seattle	Washington
United States	South Miami Women's Health	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CooperSurgical Inc.

Country where clinical trial is conducted

United States, 

Outcome

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