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

Phase 1

Completed

• Conditions: Prevention of Pregnancy
• Interventions: Device: TCu380 IUD; Device: VeraCept Intrauterine Copper Contraceptive

• Registration Number: NCT02167763
• Lead Sponsor: Sebela Women's Health Inc.

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).

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-19
• Primary Completion: 2014-12
• Study Completion: 2017-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCu380	TCu380 IUD	A commercial standard T-shaped copper IUD (TCu380)
VeraCept Intrauterine Contraceptive	VeraCept Intrauterine Copper Contraceptive	The VeraCept low-dose Intrauterine Copper Contraceptive

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain at Insertion	At Enrollment	Subject reported pain scores at device insertion
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)

Trial Locations

Locations (1)

Clinica Canela; 🇩🇴 La Romana, Dominican Republic