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

NCT03785366 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CMDOC-0045
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Women at Risk for Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  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)

  Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57

• Baseline-corrected Mean Total Serum Copper Concentration of VeraCept vs. ParaGard (Cmean)

  Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57

• Baseline-Corrected Maximum Serum Concentration of Copper for VeraCept vs. ParaGard (AUC0-56)

  Study Days Baseline (pre-insertion), 3, 8, 15, 22, 29, 57

• 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)

• 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

Study Arms (2)

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

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.

Drug: ParaGard

Interventions

VeraCept DRUG

VeraCept Intrauterine Device (IUD)

VeraCept

ParaGard DRUG

ParaGard intrauterine copper contraceptive

Also known as: ParaGard T 380A

ParaGard

Eligibility Criteria

• Age: Up to 45 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sebela Women's Health Inc.: lead
• Synteract, Inc.: collaborator

Study Sites (2)

OHSU Women's Health Research Unit

Portland, Oregon, 97239, United States

Location

Seattle Women's Health

Seattle, Washington, 98105, United States

Location

Results Point of Contact

• Title: Elizabeth Gray
• Organization: Sebela Women's Health

Elizabeth.Gray@sebelapharma.com

760.593.8383

Study Officials

• David Turok, MD, MPH

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects are blinded until the Day 57 Visit
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: December 17, 2018
• Primary Completion: December 30, 2019
• Study Completion: August 1, 2024
• Last Updated: August 15, 2025
• Results First Posted: August 15, 2025

Record last verified: 2025-08

Locations

US (2)