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

April 4, 2022 updated by: Sebela Women's Health Inc.

Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VeraCept Intrauterine Contraceptive
The VeraCept low-dose Intrauterine Copper Contraceptive
Device: VeraCept Intrauterine Copper Contraceptive
Active Comparator: TCu380
A commercial standard T-shaped copper IUD (TCu380)
Device: TCu380 IUD

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sebela Women's Health Inc.

Investigators

  • Principal Investigator: Juan M. Canela, M.D., Clinica Canela

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM2010.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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