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NCT05309694

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

Completed Phase 4 Last updated 20 January 2023
What this trial tests

Phase 4 trial testing Paragard® T380A Intrauterine Copper Contraceptive with New Inserter in Contraception in 119 participants. Completed in 8 December 2022.

Timeline
4 March 2022
Primary endpoint
8 December 2022
8 December 2022

Quick facts

Lead sponsorCooperSurgical Inc.
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment119
Start date4 March 2022
Primary completion8 December 2022
Estimated completion8 December 2022
Sites8 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperSurgical Inc.

Who can join

18 and older, female only, with Contraception. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter.
    Dunsmoor-Su RF, Desai VB, Pandolfi EC, Audette CR, et al · · 2025 · PMID 41000288 · DOI 10.1097/og9.0000000000000068

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Other recruiting trials for Contraception

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05309694.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing