Women at Risk for PregnancyPhase 3IUDNCT03785366

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

A Phase 3 study testing VeraCept and ParaGard in people with Women at Risk for Pregnancy, run by Sebela Women's Health Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women Read more about this study

Who is it for?: Ages Up to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Women at Risk for Pregnancy
What is being tested?: VeraCept and ParaGard
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 2 sitesUnited States
Study dates: 17 Dec 2018to 1 Aug 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 45 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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;

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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

Who cannot join

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;

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

OHSU Women's Health Research Unit
Portland, Oregon, 97239
Seattle Women's Health
Seattle, Washington, 98105

Other trials in United States

About this study

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

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

Conditions: Women at Risk for Pregnancy
Being tested: VeraCept, ParaGard

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VeraCeptDrug
VeraCept Intrauterine Device (IUD)
ParaGardDrug
Also called ParaGard T 380A
ParaGard intrauterine copper contraceptive

Study groups in NCT03785366
Study group	Role	What they receive
VeraCept	Experimental	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 Receives: Drug: VeraCept
ParaGard	Active comparator	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. Receives: Drug: ParaGard

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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.

Secondary outcomes (6)

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
Measured: 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
Measured: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57
Baseline-Corrected Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)
To assess the relative bioavailability of baseline-corrected total serum copper from the VeraCept IUD versus ParaGard based on AUC0-56 days
Measured: 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).
Measured: 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
Measured: 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
Measured: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 48, 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 20181 Aug 2024

First posted24 Dec 2018
Study start17 Dec 2018
Primary completion30 Dec 2019
Study completion1 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Women at Risk for PregnancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03785366
Sponsor's protocol ID: CMDOC-0045
Acronym: IUD
Status last verified: Aug 2025
First submitted: 17 Dec 2018
Last updated: 15 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Blind, Comparative Bioavailability Study to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post-Menarcheal Women
ClinicalTrials.gov ID: NCT03785366
Acronym / sponsor ID: IUD / CMDOC-0045
Conditions: Women at Risk for Pregnancy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Sebela Women's Health Inc.Industry (pharma, biotech, devices)
Collaborators: Synteract, Inc.
Study start: 17 Dec 2018 (actual)
Primary completion: 30 Dec 2019 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 24 Dec 2018 (actual)
Results: Posted 15 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
VeraCept	Experimental	Drug: VeraCeptVeraCept 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
ParaGard	Active comparator	Drug: ParaGardParaGard 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.

Who may qualify

Ages: Up to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (13 listed)

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;

Key exclusion criteria (28 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VeraCeptVeraCept Intrauterine Device (IUD)	Drug	VeraCept
ParaGardAlso: ParaGard T 380AParaGard intrauterine copper contraceptive	Drug	ParaGard

Primary outcome

Relative Maximum Observed Total Serum Copper Concentration of VeraCept vs ParaGard (Cmax)
Time frame: 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)
Time frame: 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)
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.
Assess the maximum relative bioavailability of observed systemic serum levels of copper from VeraCept versus ParaGard based on AUC0-56

6 secondary outcomes

Baseline-corrected Maximum Total Serum Copper Concentration of VeraCept vs. ParaGard (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)
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)
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
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
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
Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57, Months 6, 12, 18, 24, 30, 36, 48, 60

Results and safety

Results posted to the registry on 15 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VeraCept	21	19
ParaGard	20	17

Primary outcome: Relative Maximum Observed Total Serum Copper Concentration of VeraCept vs ParaGard (Cmax)

Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57. Mean (Standard Deviation). Unit: ng/mL

Measure	VeraCept n = 20	ParaGard n = 18
Value	1210 (202)	1300 (217)

VeraCept vs ParaGard: test to Reference geometric mean ratio: 0.930 (90% CI 0.80 to 1.25), ANCOVA

Population analysed: 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

Primary outcome: Mean Serum Concentration of Copper for VeraCept vs. ParaGard (Cmean)

Time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57. Mean (Standard Deviation). Unit: ng/mL

Measure	VeraCept n = 20	ParaGard n = 18
Value	1070 (155)	1150 (151)

Primary outcome: Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (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.. Mean (Standard Deviation). Unit: day*ng/mL

Measure	VeraCept n = 18	ParaGard n = 17
Value	59700 (8310)	63600 (8130)

Population analysed: 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

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years (60 months) for VeraCept, D57 for ParaGard. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VeraCept	0 of 20 (0%)	19 of 20 (95%)	0 of 20
ParaGard	0 of 19 (0%)	8 of 19 (42.1%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Turok, MD, MPH principal investigator

University of Utah

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VeraCept and ParaGard in people with Women at Risk for Pregnancy, run by Sebela Women's Health Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative Maximum Observed Total Serum Copper Concentration of VeraCept vs ParaGard (Cmax) (time frame: Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03785366.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.