Skip to main content
OpenTrials
Completed

NCT Number: NCT02167763

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prevention of Pregnancy

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Clinica Canela

La Romana, Dominican Republic

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VeraCept Intrauterine Copper Contraceptive

Device

TCu380 IUD

Device

Primary outcomes

  1. Contraceptive Effectiveness

    Time frame: 12 Months

    Number of subjects who become pregnant during the study period

  2. Placement Feasibility

    Time frame: At Enrollment

    Ability of the clinician to successfully place the device

Secondary outcomes

  1. Device Expulsion

    Time frame: 12 Months

    Number of subjects identified with partially or fully expelled devices

  2. Tolerability

    Time frame: 12 Months

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

  3. Pain at Insertion

    Time frame: At Enrollment

    Subject reported pain scores at device insertion

Sponsors and collaborators

Lead sponsor

Sebela Women's Health Inc.

Industry

Registry information

Official study title

Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception

Important dates

Study start
2013
Primary completion
2014
Study completion
2017
First posted
Jun 19, 2014
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.