Trials / Completed
CompletedNCT02167763
Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD
Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Sebela Women's Health Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 42 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VeraCept Intrauterine Copper Contraceptive | |
| DEVICE | TCu380 IUD |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2014-12-01
- Completion
- 2017-12-31
- First posted
- 2014-06-19
- Last updated
- 2022-04-12
Locations
1 site across 1 country: Dominican Republic
Source: ClinicalTrials.gov record NCT02167763. Inclusion in this directory is not an endorsement.