Trial Outcomes & Findings for A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs) (NCT NCT03785366)
NCT ID: NCT03785366
Last Updated: 2025-08-15
Results Overview
Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Results posted on
2025-08-15
Participant Flow
Participant milestones
| Measure |
VeraCept
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
Successful IUD Insertion
|
20
|
19
|
|
Overall Study
Early Terminations
|
1
|
2
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
VeraCept
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Overall Study
Non-Menstrual Pelvic Pain
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Partial IUD Expulsion
|
0
|
2
|
|
Overall Study
Unsuccessful IUD Insertion
|
0
|
1
|
Baseline Characteristics
A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)
Baseline characteristics by cohort
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=19 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 6.42 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 6.57 • n=7 Participants
|
28.4 years
STANDARD_DEVIATION 6.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
BMI
|
26.2 kg/m^2
STANDARD_DEVIATION 5.82 • n=5 Participants
|
25.6 kg/m^2
STANDARD_DEVIATION 6.70 • n=7 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 6.19 • n=5 Participants
|
|
Height
|
166 cm
STANDARD_DEVIATION 8.65 • n=5 Participants
|
167 cm
STANDARD_DEVIATION 6.27 • n=7 Participants
|
166 cm
STANDARD_DEVIATION 7.49 • n=5 Participants
|
|
Weight
|
72.6 kg
STANDARD_DEVIATION 18.2 • n=5 Participants
|
71.4 kg
STANDARD_DEVIATION 20.4 • n=7 Participants
|
72.0 kg
STANDARD_DEVIATION 19.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57Population: One subject in the ParaGard group discontinued from the study prior to collection of the first post-insertion sample. Therefore, the overall number of participants analyzed in the ParaGard group differs from the overall number of baseline participants
Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmax
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=18 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Relative Maximum Observed Total Serum Copper Concentration of VeraCept vs ParaGard (Cmax)
|
1210 ng/mL
Standard Deviation 202
|
1300 ng/mL
Standard Deviation 217
|
PRIMARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57Population: One subject in the ParaGard group discontinued from the study prior to collection of the first post-insertion sample. Therefore, the overall number of participants analyzed in the ParaGard group differs from the overall number of baseline participants
Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmean
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=18 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Mean Serum Concentration of Copper for VeraCept vs. ParaGard (Cmean)
|
1070 ng/mL
Standard Deviation 155
|
1150 ng/mL
Standard Deviation 151
|
PRIMARY outcome
Timeframe: 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.Population: Four subjects (2 in VeraCept group, 2 in ParaGard group) did not meet the minimum number of days for inclusion in the analyses. Therefore, the overall number of participants analyzed in each group differs from the overall number of baseline participants
Assess the maximum relative bioavailability of observed systemic serum levels of copper from VeraCept versus ParaGard based on AUC0-56
Outcome measures
| Measure |
VeraCept
n=18 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=17 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)
|
59700 day*ng/mL
Standard Deviation 8310
|
63600 day*ng/mL
Standard Deviation 8130
|
SECONDARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57Population: One subject in the ParaGard group discontinued from the study prior to collection of the first post-insertion sample. Therefore, the overall number of participants analyzed in the ParaGard group differs from the overall number of baseline participants
To assess the relative bioavailability of baseline-corrected maximum total serum copper concentration of from the VeraCept IUD versus ParaGard based on Cmax
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=18 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Baseline-corrected Maximum Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmax)
|
63.5 ng/mL
Standard Deviation 84.1
|
83.2 ng/mL
Standard Deviation 70.6
|
SECONDARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57Population: One subject in the ParaGard group discontinued from the study prior to collection of the first post-insertion sample. Therefore, the overall number of participants analyzed in the ParaGard group differs from the overall number of baseline participants
To assess the relative bioavailability of baseline-corrected mean total serum copper concentration of VeraCept IUD versus ParaGard based on Cmean
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=18 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Baseline-corrected Mean Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmean)
|
15.0 ng/mL
Standard Deviation 21.2
|
27.7 ng/mL
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57Population: One subject in the ParaGard group discontinued from the study prior to collection of the first post-insertion sample. Therefore, the overall number of participants analyzed in the ParaGard group differs from the overall number of baseline participants
To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on AUC0-56 days
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=18 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Baseline-Corrected Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)
|
992 day*ng/ml
Standard Deviation 1680
|
1620 day*ng/ml
Standard Deviation 1700
|
SECONDARY outcome
Timeframe: 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)Population: One subject in the ParaGard group discontinued from the study prior to collection of the first post-insertion sample and is not included in this table. Therefore, the overall number of participants analyzed in the ParaGard group differs from the overall number of baseline participants.
To assess the total serum copper levels within each treatment relative to the normal range (49 to 184 µg/dL).
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=18 Participants
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Baseline · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Baseline · Normal
|
20 Participants
|
18 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Baseline · High
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 3 · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 3 · Normal
|
20 Participants
|
17 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 3 · High
|
0 Participants
|
1 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 8 · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 8 · Normal
|
20 Participants
|
18 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 8 · High
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 15 · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 15 · Normal
|
20 Participants
|
18 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 15 · High
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 22 · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 22 · Normal
|
19 Participants
|
17 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 22 · High
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 29 · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 29 · Normal
|
20 Participants
|
17 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 29 · High
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 57 · Low
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 57 · Normal
|
18 Participants
|
17 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Day 57 · High
|
0 Participants
|
0 Participants
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 6 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 6 · Normal
|
18 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 6 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 12 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 12 · Normal
|
17 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 12 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 18 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 18 · Normal
|
15 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 18 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 24 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 24 · Normal
|
15 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 24 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 30 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 30 · Normal
|
12 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 30 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 36 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 36 · Normal
|
11 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 36 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 48 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 48 · Normal
|
11 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 48 · High
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 60 · Low
|
0 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 60 · Normal
|
8 Participants
|
—
|
|
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels
Month 60 · High
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60To assess the long-term stability of copper levels following insertion of the VeraCept IUD
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Long-term Stability of Copper Levels as Determined by Cmax - VeraCept Only
|
87.3 ng/mL
Standard Deviation 92.4
|
—
|
SECONDARY outcome
Timeframe: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 48, 60To assess the long-term stability of copper levels following insertion of the VeraCept IUD
Outcome measures
| Measure |
VeraCept
n=20 Participants
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Long-term Stability of Copper Levels as Determined by Cmean - VeraCept Only
|
18.7 ng/mL
Standard Deviation 24.9
|
—
|
Adverse Events
VeraCept
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
ParaGard
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VeraCept
n=20 participants at risk
VeraCept subjects will be inserted with VeraCept on Day 1. At Day 57 subjects will be informed that they received VeraCept and may continue in the study for up to 5 years
VeraCept: VeraCept Intrauterine Device (IUD)
|
ParaGard
n=19 participants at risk
ParaGard subjects will be inserted with ParaGard on Day 1. At Day 57 subjects will be informed that they received ParaGard and may choose to have the ParaGard removed or continue use per standard of clinical care.
ParaGard: ParaGard intrauterine copper contraceptive
|
|---|---|---|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
40.0%
8/20 • Number of events 12 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
25.0%
5/20 • Number of events 5 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Pelvic pain
|
20.0%
4/20 • Number of events 4 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Vaginal discharge
|
10.0%
2/20 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Adnexa uteri mass
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Cervix inflammation
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Coital bleeding
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
5.0%
1/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Vulvovaginal rash
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
10.0%
2/20 • Number of events 4 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Gastrointestinal disorders
Abdominal distension
|
15.0%
3/20 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/20 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
15.8%
3/19 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Nervous system disorders
Amnesia
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Nervous system disorders
Athetosis
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Nervous system disorders
Bell's palsy
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Nervous system disorders
Dysarthria
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Nervous system disorders
Post-traumatic headache
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Product Issues
Device expulsion
|
0.00%
0/20 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
10.5%
2/19 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Psychiatric disorders
Affect lability
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Psychiatric disorders
Depression
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Cardiac disorders
Tachycardia
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Eye disorders
Photophobia
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Investigations
Weight decreased
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Dyspareunia
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Reproductive system and breast disorders
Vaginal odour
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Bacterial vaginosis
|
15.0%
3/20 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
5.3%
1/19 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
2/20 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
10.5%
2/19 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
15.0%
3/20 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Urinary tract infection
|
5.0%
1/20 • Number of events 3 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
COVID-19
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Influenza
|
10.0%
2/20 • Number of events 2 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Endometritis
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Herpes simplex
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Infections and infestations
Papilloma viral infection
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Endocrine disorders
Hypothyroidism
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Eye disorders
Retinal detachment
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Investigations
Smear cervix abnormal
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • Number of events 1 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
0.00%
0/19 • 5 years (60 months) for VeraCept, D57 for ParaGard
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place