Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Coppe… (NCT02167763) | Clinical Trial Compass
CompletedPhase 1
Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD
Dominican Republic300 participantsStarted 2013-11
Plain-language 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.
Who can participate
Age range18 Years – 42 Years
SexFEMALE
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Inclusion Criteria:
* Adult females ages 18 to 42 (pre-menopausal)
* Have had at least one child (parous) and currently seeking long acting reversible contraception
* Normal uterine cavity as determined by ultrasound
* Willing to sign informed consent
* Able and willing to comply with study assessment schedule
Exclusion Criteria:
* Post menopausal
* Pregnant (at time of enrollment)
* Known anatomical abnormalities of uterus, cervix and/or fallopian tubes
* Diagnosed or in treatment for cancer
* Untreated acute cervicitis
* In treatment for active Pelvic Inflammatory Disease
* Unexplained uterine bleeding or menometrorrhagia
* Known allergy to copper (Wilson's Disease) or imaging contrast media
* Unsuitable for study participation in the opinion of the Principal Investigator