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NCT05309694 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study of Contraception, sponsored by CooperSurgical.

Completed
Registry status
Phase 4
Development phase
119
Enrollment target
8
Study locations

NCT05309694 is a Phase 4 study of Contraception that has completed, run by CooperSurgical. The registered enrollment target is 119 participants, below the 453-participant average among 72 other Contraception trials with a reported enrollment target (74% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT05309694, a Phase 4 study of Contraception, has completed, sponsored by CooperSurgical.

COMPLETED
Registry status
Phase 4
Development phase
119 participants
Enrollment target
8
Study locations

Study 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 Studied

Interventions

  • COMBINATION_PRODUCT Paragard® T380A Intrauterine Copper Contraceptive with New Inserter

Study Locations (8)

Texas

  • Central Austin - Women Partners in Health - Austin
  • Austin Area Ob-Gyn & Fertility - Austin

Colorado

  • Downtown Women's Healthcare - Denver

Florida

  • South Miami Women's Health - South Miami

Georgia

  • GYN-CARE Women's Healthcare - Atlanta

Michigan

  • Valley Ob-Gyn Clinic, PC - Saginaw

Ohio

  • Hilltop Obstetrics & Gynecology - Franklin

Washington

  • Seattle Clinical Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 119 participants
Start Date 2022-03-04
Est. Completion 2022-12-08
Phase Phase 4

Sponsor

CooperSurgical

2 total trials

What the Registry Record Tells You About NCT05309694

The ClinicalTrials.gov registry entry for NCT05309694 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 453-participant average among 72 other Contraception trials with a reported enrollment target (74% lower). The listed sponsor is CooperSurgical, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Contraception appearing as the primary indexed condition, and to 1 intervention - of which Paragard® T380A Intrauterine Copper Contraceptive with New Inserter is the first listed.

NCT05309694 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Texas, Colorado, Florida.

Frequently Asked Questions

What is clinical trial NCT05309694 about?

NCT05309694 is a clinical study titled "A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)". 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.

What is the current status of trial NCT05309694?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 119 participants. The study started on 2022-03-04. Estimated completion is 2022-12-08.

What conditions does trial NCT05309694 study?

This clinical trial studies the following conditions: Contraception.

What interventions are being tested in trial NCT05309694?

The interventions under investigation include: Paragard® T380A Intrauterine Copper Contraceptive with New Inserter (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT05309694?

This trial is sponsored by CooperSurgical, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05309694 being conducted?

This trial has 8 study locations across Colorado, Florida, Georgia, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.