Comparative Study of the VeraCept Low-Dose Intrauterine Copper Contraceptive vs. the TCu380 Copper IUD

Sebela Women's Health Inc.300 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

300

Conditions

Prevention of Pregnancy

Interventions

VeraCept Intrauterine Copper ContraceptiveDEVICE

TCu380 IUDDEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinica Canela

La Romana, Dominican Republic

Outcomes

Primary Outcomes

Contraceptive Effectiveness

Number of subjects who become pregnant during the study period

Time frame: 12 Months

Placement Feasibility

Ability of the clinician to successfully place the device

Time frame: At Enrollment

Secondary Outcomes

Device Expulsion

Number of subjects identified with partially or fully expelled devices

Time frame: 12 Months

Tolerability

Number of subjects who request device removal due to inability to tolerate the intervention (device)

Time frame: 12 Months

Pain at Insertion

Subject reported pain scores at device insertion

Time frame: At Enrollment

Data from ClinicalTrials.gov

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