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

Overview

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.

Full Title of Study: “Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2014

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).

Interventions

  • Device: VeraCept Intrauterine Copper Contraceptive
  • Device: TCu380 IUD

Arms, Groups and Cohorts

  • Experimental: VeraCept Intrauterine Contraceptive
    • The VeraCept low-dose Intrauterine Copper Contraceptive
  • Active Comparator: TCu380
    • A commercial standard T-shaped copper IUD (TCu380)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Sebela Women’s Health Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Juan M. Canela, M.D., Principal Investigator, Clinica Canela

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