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The purpose of this study is to evaluate the safety and effectiveness of the VeraCept Low Dose Intrauterine Copper Contraceptive compared to the standard T shaped copper IUD, the TCu380.
This is a prospective, randomized, subject-blinded, two arm controlled study of the Safety, Feasibility and Effectiveness of the VeraCept low-dose intrauterine copper contraceptive as compared to a concurrently controlled, commercially available standard copper "T" IUD (TCu380).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VeraCept Intrauterine Contraceptive | Experimental | The VeraCept low-dose Intrauterine Copper Contraceptive |
|
| TCu380 | Active Comparator | A commercial standard T-shaped copper IUD (TCu380) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VeraCept Intrauterine Copper Contraceptive | Device |
| ||
| TCu380 IUD |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Effectiveness | Number of subjects who become pregnant during the study period | 12 Months |
| Placement Feasibility | Ability of the clinician to successfully place the device | At Enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Device Expulsion | Number of subjects identified with partially or fully expelled devices | 12 Months |
| Tolerability | Number of subjects who request device removal due to inability to tolerate the intervention (device) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan M. Canela, M.D. | Clinica Canela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Canela | La Romana | Dominican Republic |
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| Device |
|
| 12 Months |
| Pain at Insertion | Subject reported pain scores at device insertion | At Enrollment |