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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: Completed Phase 4 study of Contraception, sponsored by CooperSurgical.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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. A successful insertion includes participants with at least one successful insertion attempt with a maximum of two attempts.
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 |
What the finished NCT05309694 record still lists
NCT05309694 is an interventional study that assigns participants to a tested intervention. The registered 119 participants enrollment target is mid-sized for trials with a published cap, below the 453-participant average among 72 other Contraception trials with a reported enrollment target (74% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Contraception
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05309694's enrollment target sits among peer trials
119 41st of 72 higher than 31 of 72 other Contraception trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Contraception trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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