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

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ClinicalTrials.gov Identifier: NCT02167763
Recruitment Status : Active, not recruiting
First Posted : June 19, 2014
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
ContraMed LLC

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.

Condition or disease Intervention/treatment Phase
Prevention of Pregnancy Device: VeraCept Intrauterine Copper Contraceptive Device: TCu380 IUD Phase 1

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : December 2017

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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02167763


Locations
Dominican Republic
Clinica Canela
La Romana, Dominican Republic
Sponsors and Collaborators
ContraMed LLC
Investigators
Principal Investigator: Juan M. Canela, M.D. Clinica Canela

Responsible Party: ContraMed LLC
ClinicalTrials.gov Identifier: NCT02167763     History of Changes
Other Study ID Numbers: CM2010.01
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017

Keywords provided by ContraMed LLC:
contraception
IUD
copper

Additional relevant MeSH terms:
Contraceptive Agents
Copper
Reproductive Control Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances