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

NCT ID: NCT05309694

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-04
• Study Completion Date: 2022-12-08

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1

Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential

Group Type: OTHER

Paragard® T380A Intrauterine Copper Contraceptive with New Inserter

Intervention Type: 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

CooperSurgical Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Kroll, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Clinical Research Center

Carol Stamm, MD

Role: PRINCIPAL_INVESTIGATOR

Downtown Women's Healthcare

Joyce Miller, MD

Role: PRINCIPAL_INVESTIGATOR

South Miami Women's Health

Jacquelyn Robinson, MD

Role: PRINCIPAL_INVESTIGATOR

Valley Ob-Gyn Clinic, PC

Ronald Hirth, MD

Role: PRINCIPAL_INVESTIGATOR

Hilltop Obstetrics & Gynecology

Mark Akin, MD

Role: PRINCIPAL_INVESTIGATOR

Austin Area Ob-Gyn & Fertility

Stephanie Reich, MD

Role: PRINCIPAL_INVESTIGATOR

Central Austin - Women Partners in Health

Eric L Brown, MD

Role: PRINCIPAL_INVESTIGATOR

GYN-CARE Women's Healthcare

Locations

Downtown Women's Healthcare

Denver, Colorado, United States

South Miami Women's Health

South Miami, Florida, United States

GYN-CARE Women's Healthcare

Atlanta, Georgia, United States

Valley Ob-Gyn Clinic, PC

Saginaw, Michigan, United States

Hilltop Obstetrics & Gynecology

Franklin, Ohio, United States

Central Austin - Women Partners in Health

Austin, Texas, United States

Austin Area Ob-Gyn & Fertility

Austin, Texas, United States

Seattle Clinical Research Center

Seattle, Washington, United States

Countries

United States

References

Dunsmoor-Su RF, Desai VB, Pandolfi EC, Audette CR, Miller JR, Fuller AE, Brown EL, Hirth RD, Seetal-Kihei KV, McKain LF. Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter. O G Open. 2025 Mar 6;2(2):e068. doi: 10.1097/og9.0000000000000068. eCollection 2025 Apr.

Reference Type: DERIVED

PMID: 41000288 (View on PubMed)

Other Identifiers

CSIPD-001

Identifier Type: -

Identifier Source: org_study_id