NCT02167763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

June 17, 2014

Last Update Submit

April 4, 2022

Conditions

Prevention of Pregnancy

Keywords

contraceptionIUDcopper

Outcome Measures

Primary Outcomes (2)

  • Contraceptive Effectiveness

    Number of subjects who become pregnant during the study period

    12 Months

  • Placement Feasibility

    Ability of the clinician to successfully place the device

    At Enrollment

Secondary Outcomes (3)

  • Device Expulsion

    12 Months

  • Tolerability

    12 Months

  • Pain at Insertion

    At Enrollment

Study Arms (2)

VeraCept Intrauterine Contraceptive

EXPERIMENTAL

The VeraCept low-dose Intrauterine Copper Contraceptive

Device: VeraCept Intrauterine Copper Contraceptive

TCu380

ACTIVE COMPARATOR

A commercial standard T-shaped copper IUD (TCu380)

Device: TCu380 IUD

Interventions

VeraCept Intrauterine Copper ContraceptiveDEVICE
VeraCept Intrauterine Contraceptive
TCu380 IUDDEVICE
TCu380

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Canela

La Romana, Dominican Republic

Location

Study Officials

  • Juan M. Canela, M.D.

    Clinica Canela

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 19, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 31, 2017

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

DO(1)