Overview

This trial is active, not recruiting.

Condition prevention of pregnancy
Treatments veracept intrauterine copper contraceptive, tcu380 iud
Phase phase 1
Sponsor ContraMed LLC
Start date November 2013
End date December 2014
Trial size 300 participants
Trial identifier NCT02167763, CM2010.01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
The VeraCept low-dose Intrauterine Copper Contraceptive
veracept intrauterine copper contraceptive
(Active Comparator)
A commercial standard T-shaped copper IUD (TCu380)
tcu380 iud

Primary Outcomes

Measure
Contraceptive Effectiveness
time frame: 12 Months
Placement Feasibility
time frame: At Enrollment

Secondary Outcomes

Measure
Device Expulsion
time frame: 12 Months
Tolerability
time frame: 12 Months
Pain at Insertion
time frame: At Enrollment

Eligibility Criteria

Female participants from 18 years up to 42 years old.

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

Additional Information

Official title Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
Principal investigator Juan M. Canela, M.D.
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).
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by ContraMed LLC.