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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02167763

Enrollment

300

Registered

2014-06-19

Start date

2013-11-30

Completion date

2017-12-31

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Pregnancy

Keywords

contraception, IUD, copper

Brief 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).

Interventions

DEVICEVeraCept Intrauterine Copper Contraceptive

DEVICETCu380 IUD

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Contraceptive Effectiveness	12 Months	Number of subjects who become pregnant during the study period
Placement Feasibility	At Enrollment	Ability of the clinician to successfully place the device

Secondary

Measure	Time frame	Description
Device Expulsion	12 Months	Number of subjects identified with partially or fully expelled devices
Tolerability	12 Months	Number of subjects who request device removal due to inability to tolerate the intervention (device)
Pain at Insertion	At Enrollment	Subject reported pain scores at device insertion

Countries

Dominican Republic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026