to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
41
OHSU Women's Health Research Unit
Portland, Oregon, United States
Seattle Women's Health
Seattle, Washington, United States
Relative Maximum Observed Total Serum Copper Concentration of VeraCept vs ParaGard (Cmax)
Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmax
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Mean Serum Concentration of Copper for VeraCept vs. ParaGard (Cmean)
Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmean
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)
Assess the maximum relative bioavailability of observed systemic serum levels of copper from VeraCept versus ParaGard based on AUC0-56
Time frame: From Baseline (pre-insertion) through the last measurable non-zero concentration, up to Day 57 (56 days post-insertion), with a minimum of 50 days post-insertion required for inclusion.
Baseline-corrected Maximum Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmax)
To assess the relative bioavailability of baseline-corrected maximum total serum copper concentration of from the VeraCept IUD versus ParaGard based on Cmax
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Baseline-corrected Mean Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmean)
To assess the relative bioavailability of baseline-corrected mean total serum copper concentration of VeraCept IUD versus ParaGard based on Cmean
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Baseline-Corrected Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)
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To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on AUC0-56 days
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
To assess the total serum copper levels within each treatment relative to the normal range (49 to 184 µg/dL).
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57 (VeraCept and ParaGard), Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 (VeraCept only)
Long-term Stability of Copper Levels as Determined by Cmax - VeraCept Only
To assess the long-term stability of copper levels following insertion of the VeraCept IUD
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60
Long-term Stability of Copper Levels as Determined by Cmean - VeraCept Only
To assess the long-term stability of copper levels following insertion of the VeraCept IUD
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 48, 60