Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS

NCT03633799 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 1 other identifier: CMDOC-0042
• Study Type: interventional
• Target: 1,620
• Locations: 1 country
• Sites: 41

Brief Summary

To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept

Conditions

Women at Risk for Pregnancy

Outcome Measures

Primary Outcomes (1)

• Contraceptive Efficacy Through 3 Years of Use

  Contraceptive efficacy through 3 years of use, as assessed by the Pearl Index. The Pearl Index is calculated as the number of on-treatment pregnancies per 100 woman-years of exposure. On-treatment pregnancy is defined as the estimated conception date being on or after the insertion date (must be a successful insertion) and no more than 7 days after the study drug is removed or expelled. One women year is defined as comprising thirteen 28-day cycles. A lower Pearl Index indicates greater contraceptive effectiveness.

  3 years

Secondary Outcomes (10)

• Contraceptive Efficacy at Years 4, 5, 6, 7 and 8

  Years 4, 5, 6, 7, and 8 and cumulatively through Years 4, 5, 6, 7, and 8

• Cumulative Pregnancy Percentage

  Years 1 through 3

• Ease of VeraCept Placement

  Visit 1 (Day 1) / VeraCept placement

• VeraCept Placement Success

  Visit 1 (Day 1) / VeraCept placement

• Bleeding and Spotting Patterns

  Through year 1

Study Arms (1)

VeraCept

EXPERIMENTAL

VeraCept® Intrauterine Contraceptive

Drug: VeraCept

Interventions

VeraCept DRUG

VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method

VeraCept

Eligibility Criteria

• Age: Up to 45 Years
• Gender Eligibility Details: Only women who are at risk for pregnancy will be eligible for this study
• 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 must be in compliance with cervical cancer screening guidelines per the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines without evidence of disease. Subjects who are age 21-24 y/o, at time of informed consent, must have a normal Papanicolaou test (Pap), atypical squamous cells of undetermined significance (ASC-US), or low-grade squamous intraepithelial lesion (LSIL). Subjects who are 25 or older at the time of informed consent with ASC-US results, must also have a 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 IUS insertion. Alternatively, the subject must have had a colposcopy performed within the appropriate screen timeframe, and prior to the study IUS 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 (including e-diary) 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;
• Subject who anticipates separation from her partner for more than a 6-month period during use of VeraCept;
• A previously inserted intrauterine system (IUS) that has not been removed by the time the study IUS is placed;
• History of previous IUS complications, such as perforation, expulsion, or pregnancy with IUS in place;
• Pain with current IUS;
• Injection of hormonal contraceptive (e.g., Depo-Provera) within the last 10 months and has not had 2 normal menstrual cycles since the last injection;
• Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during 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

Sponsors & Collaborators

• Sebela Women's Health Inc.: lead
• Syneos Health: collaborator

Study Sites (41)

MomDoc Women's Health Research

Scottsdale, Arizona, 85251, United States

Location

Copperstate OB/GYN Associates

Tucson, Arizona, 85712, United States

Location

Essential Access Health

Berkeley, California, 94710, United States

Location

Essential Access Health

Los Angeles, California, 90010, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

University of California, Davis Health System

Sacramento, California, 95817, United States

Location

M3 Wake Research (formerly Women's Health Care Research)

San Diego, California, 92111, United States

Location

M3 Wake Research (formerly Medical Center for Clinical Research)

San Diego, California, 92120, United States

Location

Stanford University, Medical Center, Obstetrics and Gynecolocy

Stanford, California, 94305, United States

Location

Velocity Clinical Research (formerly Downtown Women's Health Care)

Englewood, Colorado, 80110, United States

Location

Altus Research, Inc

Lake Worth, Florida, 33461, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30308, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 30034, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Women's Health Advantage

Fort Wayne, Indiana, 46825, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Praetorian Pharmaceutical Research

Marrero, Louisiana, 70072, United States

Location

University of Michigan Von Voigtlander Women's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Planned Parenthood North Central States - Minneapolis

Minneapolis, Minnesota, 55408, United States

Location

Planned Parenthood Great Rivers (formerly Planned Parenthood of the St. Louis Region and Southwest Missouri)

Manchester, Missouri, 63088, United States

Location

Rex Garn Mabey Jr., MD

Las Vegas, Nevada, 89128, United States

Location

Capital Health Lawrence OBGYN Research (formerly Lawrence OB/Gyn Clinical Research)

Lawrenceville, New Jersey, 08648, United States

Location

Columbia University Medical Center, Division of Family Planning

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati/Reproductive Medicine Research

Cincinnati, Ohio, 45267, United States

Location

The Ohio State University Ob/Gyn Research Office

Columbus, Ohio, 43210, United States

Location

OHSU Women's Health Research Unit

Portland, Oregon, 97239, United States

Location

University of Pennsylvania/Penn Family Planning and Pregnancy Loss Center

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, 19114, United States

Location

Magee-Womens Hospital, Center for Family Planning Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical Research South, LLC

Charleston, South Carolina, 29407, United States

Location

Chattanooga Medical Research

Chattanooga, Tennessee, 37404, United States

Location

The Jackson Clinic, PA

Jackson, Tennessee, 38305, United States

Location

Advanced Research Associates

Corpus Christi, Texas, 78414, United States

Location

Advances In Health

Pearland, Texas, 77584, United States

Location

Wasatch Clinical Research

Salt Lake City, Utah, 84107, United States

Location

University of Utah Healthcare Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

Tidewater Physicians for Women

Norfolk, Virginia, 23502, United States

Location

Eastern Virginia Medical

Norfolk, Virginia, 23507, United States

Location

Seattle Clinical REsearch Center (formerly Seattle Women's Health)

Seattle, Washington, 98104, United States

Location

University of Washington Medical Center

Seattle, Washington, 98117, United States

Location

Related Publications (1)

• Creinin MD, Gawron LM, Roe AH, Blumenthal PD, Boraas CM, Hou MY, McNicholas C, Schreifels MJ, Peters K, Culwell K, Turok DK; Copper 175mm(2) IUD Phase 3 Clinical Investigator Group. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception. 2025 Mar;143:110771. doi: 10.1016/j.contraception.2024.110771. Epub 2024 Nov 22.

  PMID: 39581486 DERIVED

Results Point of Contact

• Title: Elizabeth Gray, Manager, Clinical Operations
• 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: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: VeraCept Intrauterine System (IUS)

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 16, 2018
• Study Start: August 22, 2018
• Primary Completion: September 22, 2022
• Study Completion (Estimated): September 22, 2027
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (41)