A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)

A Randomized, Single-Blind, Comparative Bioavailability Study to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post-Menarcheal Women

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03785366

Acronym

IUD

Enrollment

Registered

2018-12-24

Start date

2018-12-17

Completion date

2024-08-01

Last updated

2025-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women at Risk for Pregnancy

Brief summary

to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women

Interventions

DRUGVeraCept

VeraCept Intrauterine Device (IUD)

DRUGParaGard

ParaGard intrauterine copper contraceptive

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Masking description

Subjects are blinded until the Day 57 Visit

Eligibility

Sex/Gender

FEMALE

Age

No minimum to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed consent/assent and in good general health; * History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones or prior to recent pregnancy or spontaneous or induced abortion; * Sexually active with a male partner who has not had a vasectomy; * Reasonably expect to have coitus at least once monthly during the study period; * In a mutually monogamous relationship of at least 3 months duration; * Seeking to avoid pregnancy for the duration of the study; * Willing to use the study drug as the sole form of contraception; * Willing to accept a risk of pregnancy; * Subjects who are age 21 or older, at time of informed consent, must have a normal papanicolaou test (Pap) or atypical squamous cells of undetermined significance (ASC-US) with negative high risk human papilloma virus (HPV) test result within the appropriate screen timeframe per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines, and prior to the study IUD insertion. Alternatively, the subject must have had a colposcopy performed within the appropriate screen timeframe, and prior to the study IUD insertion that showed no evidence of dysplasia requiring treatment per ASCCP guidelines, or treatment was performed and follow-up at least 6 months after the treatment showed no evidence of disease by clinical evaluation; * Able and willing to comply with all study tests, procedures, assessment tools and follow-up; * Able and willing to provide and document informed consent and Authorization for Release of Protected Health Information (PHI). Unemancipated subjects under 18 years old must provide assent and have written parental consent documented on the consent form consistent with local legal requirements; * Plan to reside within a reasonable driving distance of a research site for the duration of the study. * Subject agrees not to self-remove VeraCept

Exclusion criteria

* Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle; * A previously inserted intrauterine device (IUD) that has not been removed by the time the study IUD is placed; * History of previous IUD complications, such as perforation, expulsion, or pregnancy with IUD in place; * Pain with current IUD; * Use of ParaGard IUD within the past 3 months * Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 60 months of study participation; * Exclusively breastfeeding before return of menses; lactating women will be excluded unless they have had 2 normal menstrual periods prior to enrollment; * Unexplained abnormal uterine bleeding (suspicious for a serious condition), including bleeding 4 weeks post-septic abortion or puerperal sepsis; * Severely heavy or painful menstrual bleeding; * Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal Pap smear requiring evaluation or treatment; * Any history of gestational trophoblastic disease with or without detectable elevated ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease; * Any congenital or acquired uterine anomaly that may complicate study drug placement, such as: * Submucosal uterine leiomyoma * Asherman's syndromes * Pedunculated polyps * Bicornuate uterus * Didelphus or uterine septa * Any distortions of the uterine cavity (e.g. fibroids), that, in the opinion of the investigator, are likely to cause issues during insertion, retention or removal of the IUD; * Untreated acute cervicitis or vaginitis within the past 3 months; * Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS; * Subjects who have an established immunodeficiency; * Known intolerance or allergy to any components of VeraCept or ParaGard including intolerance or allergy to nickel, titanium, or copper, and including Wilson's Disease; * Currently participating or planning future participation in a research study of an investigational drug or device during the course of this investigational study. Subject must have waited at least 30 days from exiting their last study prior to informed consent in this study; * Subject has been enrolled in a previous VeraCept study; * Known or suspected alcohol or drug abuse within 12 months prior to the screening visit; * Any general health, mental health or behavioral condition that, in the opinion of the investigator, could represent an increased risk for the subject or would render the subject less likely to provide the needed study information; * Study staff or a member of the immediate family of study staff. * Concurrent use of corticosteroids

Design outcomes

Primary

Measure	Time frame	Description
Relative Maximum Observed Total Serum Copper Concentration of VeraCept vs ParaGard (Cmax)	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57	Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmax
Mean Serum Concentration of Copper for VeraCept vs. ParaGard (Cmean)	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57	Assess the relative bioavailability of observed systemic copper from VeraCept versus ParaGard based on Cmean
Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)	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.	Assess the maximum relative bioavailability of observed systemic serum levels of copper from VeraCept versus ParaGard based on AUC0-56

Secondary

Measure	Time frame	Description
Total Serum Copper Levels of VeraCept vs. ParaGard Compared to Normal Copper Levels	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)	To assess the total serum copper levels within each treatment relative to the normal range (49 to 184 µg/dL).
Baseline-corrected Maximum Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmax)	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57	To assess the relative bioavailability of baseline-corrected maximum total serum copper concentration of from the VeraCept IUD versus ParaGard based on Cmax
Long-term Stability of Copper Levels as Determined by Cmean - VeraCept Only	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 48, 60	To assess the long-term stability of copper levels following insertion of the VeraCept IUD
Long-term Stability of Copper Levels as Determined by Cmax - VeraCept Only	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 42, 48, 54, 60	To assess the long-term stability of copper levels following insertion of the VeraCept IUD
Baseline-corrected Mean Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmean)	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57	To assess the relative bioavailability of baseline-corrected mean total serum copper concentration of VeraCept IUD versus ParaGard based on Cmean
Baseline-Corrected Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)	Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57	To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on AUC0-56 days

Countries

United States

Participant flow

Participants by arm

Arm	Count
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)	20
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	19
Total	39

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0
Overall Study	Non-Menstrual Pelvic Pain	1	0
Overall Study	Partial IUD Expulsion	0	2
Overall Study	Unsuccessful IUD Insertion	0	1

Baseline characteristics

Characteristic	VeraCept	ParaGard	Total
Age, Continuous	27.0 years STANDARD_DEVIATION 6.42	29.9 years STANDARD_DEVIATION 6.57	28.4 years STANDARD_DEVIATION 6.57
BMI	26.2 kg/m^2 STANDARD_DEVIATION 5.82	25.6 kg/m^2 STANDARD_DEVIATION 6.7	25.9 kg/m^2 STANDARD_DEVIATION 6.19
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants	0 Participants	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants	19 Participants	38 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Height	166 cm STANDARD_DEVIATION 8.65	167 cm STANDARD_DEVIATION 6.27	166 cm STANDARD_DEVIATION 7.49
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	4 Participants	3 Participants	7 Participants
Race (NIH/OMB) Black or African American	0 Participants	3 Participants	3 Participants
Race (NIH/OMB) More than one race	4 Participants	1 Participants	5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	11 Participants	12 Participants	23 Participants
Sex: Female, Male Female	20 Participants	19 Participants	39 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants
Weight	72.6 kg STANDARD_DEVIATION 18.2	71.4 kg STANDARD_DEVIATION 20.4	72.0 kg STANDARD_DEVIATION 19.1

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 20	0 / 19
other Total, other adverse events	19 / 20	8 / 19
serious Total, serious adverse events	0 / 20	0 / 19

Outcome results

Primary

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.

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

Arm	Measure	Value (MEAN)	Dispersion
VeraCept	Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)	59700 day*ng/mL	Standard Deviation 8310
ParaGard	Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)	63600 day*ng/mL	Standard Deviation 8130

Primary

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