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

NCT05309694 | Completed Phase 4 FDA Drug

• 1 other identifier: CSIPD-001
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 8

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.

Conditions

Contraception

Keywords

Contraception; Copper Intrauterine Device; Intrauterine Device; Contraceptive; Birth Control; IUD; IUS; Intrauterine System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Uterine Perforation and IUD Embedment

  From enrollment to end of treatment at 3 months

• IUS Expulsions and Dislocations

  From enrollment to end of treatment at 3 months

• Adverse Events

  From enrollment to end of treatment at 3 months

• Adverse Events related to Procedure

  From enrollment to end of treatment at 3 months

• Vasovagal Events

  From enrollment to end of treatment at 3 months

Study Arms (1)

Group 1

OTHER

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

Interventions

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperSurgical Inc.: lead

Study Sites (8)

Downtown Women's Healthcare

Denver, Colorado, 80218, United States

Location

South Miami Women's Health

South Miami, Florida, 33143, United States

Location

GYN-CARE Women's Healthcare

Atlanta, Georgia, 30363, United States

Location

Valley Ob-Gyn Clinic, PC

Saginaw, Michigan, 48602, United States

Location

Hilltop Obstetrics & Gynecology

Franklin, Ohio, 45005, United States

Location

Central Austin - Women Partners in Health

Austin, Texas, 78705, United States

Location

Austin Area Ob-Gyn & Fertility

Austin, Texas, 78758, United States

Location

Seattle Clinical Research Center

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• 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.

  PMID: 41000288 DERIVED

Study Officials

• Robin Kroll, MD

  Seattle Clinical Research Center

  PRINCIPAL INVESTIGATOR

• Carol Stamm, MD

  Downtown Women's Healthcare

  PRINCIPAL INVESTIGATOR

• Joyce Miller, MD

  South Miami Women's Health

  PRINCIPAL INVESTIGATOR

• Jacquelyn Robinson, MD

  Valley Ob-Gyn Clinic, PC

  PRINCIPAL INVESTIGATOR

• Ronald Hirth, MD

  Hilltop Obstetrics & Gynecology

  PRINCIPAL INVESTIGATOR

• Mark Akin, MD

  Austin Area Ob-Gyn & Fertility

  PRINCIPAL INVESTIGATOR

• Stephanie Reich, MD

  Central Austin - Women Partners in Health

  PRINCIPAL INVESTIGATOR

• Eric L Brown, MD

  GYN-CARE Women's Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm and open-label design

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 4, 2022
• Study Start: March 4, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)