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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2022-03-04 |
| Est. Completion | 2022-12-08 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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Read our methodology - how this data is sourced, computed, and verified.
Related
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.