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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Study of the VeraCept Intrauterine Device for Long Acting Reversible Contraception

Conditions
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Prevention of Pregnancy

Intervention / Treatment
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* Device: VeraCept Intrauterine Copper Contraceptive
* Device: TCu380 IUD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraception, IUD, copper