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NCT05309694
A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Phase 4 trial testing Paragard® T380A Intrauterine Copper Contraceptive with New Inserter in Contraception in 119 participants. Completed in 8 December 2022.
8 December 2022
Quick facts
| Lead sponsor | CooperSurgical Inc. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 119 |
| Start date | 4 March 2022 |
| Primary completion | 8 December 2022 |
| Estimated completion | 8 December 2022 |
| Sites | 8 locations across United States |
Drugs / interventions tested
- Paragard® T380A Intrauterine Copper Contraceptive with New Inserter
Conditions studied
- Contraception — all drugs for Contraception →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05309694
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Contraception
Currently open trials in the same condition.
- NCT07365904 — Investigating Ovulation Inhibition for Use as a Contraceptive · Phase 2 · recruiting
- NCT07437495 — Women's Knowledge of Contraception During the Postpartum Period · active not recruiting
- NCT06823037 — Hormonal Contraception Access Through Pharmacist Prescribing Implementation · NA · recruiting
- NCT07326007 — Verbal Analgesia Versus Standard Technique for Pain Control During Copper T380A Intrauterine Device Insertion in Women W · NA · recruiting
- NCT05910580 — Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05309694 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CooperSurgical Inc.
- Last refreshed: 20 January 2023
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