Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS

NCT ID: NCT03633799

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-22
• Study Completion Date: 2027-09-22

Brief Summary

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

Detailed Description

Study Design:

Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 8 years

Number of Subjects:

Approximately 1,605 subjects will be enrolled into the study

Study Population:

Post-menarcheal, pre-menopausal women up to age 45 years, who are at risk for pregnancy and who desire a long-term intrauterine contraceptive for birth control will be eligible for this study.

Primary Endpoint:

The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index.

Secondary endpoints:

Contraceptive Efficacy:

• Pearl Index at Years 4, 5, 6, 7 and 8 as well as cumulatively through Years 4, 5, 6, 7 and 8.
• Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4, 5, 6, 7 and 8
• The cumulative Pearl Index for Years 6 to 8 will be calculated as well as the cumulative pregnancy percentage for Years 6 to 8 using a life table analysis (Kaplan-Meier) only for the EP population.

Study drug placement:

• Ease of VeraCept placement
• Placement success

Safety:

• Serious adverse events (SAEs)
• Adverse events (AEs)
• Pelvic infection (pelvic inflammatory disease (PID) or endometritis)
• Ectopic pregnancies
• Uterine perforations
• Dysmenorrhea
• Abdominal pain
• Expulsion rates at Years 1, 2, 3, 4, 5, 6, 7 and 8

Tolerability:

• Bleeding and spotting patterns
• Insertion pain assessed immediately after insertion
• Continuation rates at Years 1, 2, 3, 4, 5, 6, 7 and 8
• Reasons for discontinuation

Return to fertility

● Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant. Subjects who desire pregnancy after having VeraCept removed will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.

Conditions

Women at Risk for Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VeraCept

VeraCept® Intrauterine Contraceptive

Group Type: EXPERIMENTAL

VeraCept

Intervention Type: DRUG

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

Interventions

VeraCept

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Post-menarcheal, pre-menopausal females up to 45 years of age at the time of informed consent/assent and in good general health;

2. 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;

3. Sexually active with a male partner who has not had a vasectomy;

4. Reasonably expect to have coitus at least once monthly during the study period;

5. In a mutually monogamous relationship of at least 3 months duration;

6. Seeking to avoid pregnancy for the duration of the study;

7. Willing to use the study drug as the sole form of contraception;

8. Willing to accept a risk of pregnancy;

9. 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;

10. Able and willing to comply with all study tests, procedures, assessment tools (including e-diary) and follow-up;

11. 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;

12. Plan to reside within a reasonable driving distance of a research site for the duration of the study.

13. Subject agrees not to self-remove VeraCept

Exclusion Criteria

1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle;

2. Subject who anticipates separation from her partner for more than a 6-month period during use of VeraCept;

3. A previously inserted intrauterine system (IUS) that has not been removed by the time the study IUS is placed;

4. History of previous IUS complications, such as perforation, expulsion, or pregnancy with IUS in place;

5. Pain with current IUS;

6. 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;

7. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during study participation;

8. Exclusively breastfeeding before return of menses; lactating women will be excluded unless they have had 2 normal menstrual periods prior to enrollment;

9. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including bleeding 4 weeks post-septic abortion or puerperal sepsis;

10. Severely heavy or painful menstrual bleeding;

11. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal Pap smear requiring evaluation or treatment;

12. Any history of gestational trophoblastic disease with or without detectable elevated ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;

13. 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

14. 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 IUS;

15. Known anatomical abnormalities of the cervix such as severe cervical stenosis, prior trachelectomy or extensive conization that, in the opinion of the investigator would prevent cervical dilation and study drug placement;

16. Untreated or unresolved acute cervicitis or vaginitis;

17. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;

18. Subjects who have an established immunodeficiency;

19. Known intolerance or allergy to any components of VeraCept including intolerance or allergy to nickel, titanium, or copper, and including Wilson's Disease;

20. 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;

21. Subject has been enrolled in a previous VeraCept or LevoCept study; 21a. Subject has been enrolled in a previous VeraCept or LevoCept study where VeraCept or LevoCept placement was successful or attempted (replaces exclusion #21 for PK sub-study subjects only);

22. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;

23. 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;

24. Study staff or a member of the immediate family of study staff.

25. Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)

• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Syneos Health

OTHER

Sponsor Role: collaborator

Sebela Women's Health Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Turok, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

MomDoc Women's Health Research

Scottsdale, Arizona, United States

Copperstate OB/GYN Associates

Tucson, Arizona, United States

Essential Access Health

Berkeley, California, United States

Essential Access Health

Los Angeles, California, United States

Empire Clinical Research

Pomona, California, United States

University of California, Davis Health System

Sacramento, California, United States

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

San Diego, California, United States

M3 Wake Research (formerly Medical Center for Clinical Research)

San Diego, California, United States

Stanford University, Medical Center, Obstetrics and Gynecolocy

Stanford, California, United States

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

Englewood, Colorado, United States

Altus Research, Inc

Lake Worth, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Soapstone Center for Clinical Research

Decatur, Georgia, United States

Clinical Research Prime

Idaho Falls, Idaho, United States

Women's Health Advantage

Fort Wayne, Indiana, United States

Indiana University

Indianapolis, Indiana, United States

Praetorian Pharmaceutical Research

Marrero, Louisiana, United States

University of Michigan Von Voigtlander Women's Hospital

Ann Arbor, Michigan, United States

Planned Parenthood North Central States - Minneapolis

Minneapolis, Minnesota, United States

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

Manchester, Missouri, United States

Rex Garn Mabey Jr., MD

Las Vegas, Nevada, United States

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

Lawrenceville, New Jersey, United States

Columbia University Medical Center, Division of Family Planning

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Cincinnati/Reproductive Medicine Research

Cincinnati, Ohio, United States

The Ohio State University Ob/Gyn Research Office

Columbus, Ohio, United States

OHSU Women's Health Research Unit

Portland, Oregon, United States

University of Pennsylvania/Penn Family Planning and Pregnancy Loss Center

Philadelphia, Pennsylvania, United States

Clinical Research of Philadelphia

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital, Center for Family Planning Research

Pittsburgh, Pennsylvania, United States

Medical Research South, LLC

Charleston, South Carolina, United States

Chattanooga Medical Research

Chattanooga, Tennessee, United States

The Jackson Clinic, PA

Jackson, Tennessee, United States

Advanced Research Associates

Corpus Christi, Texas, United States

Advances In Health

Pearland, Texas, United States

Wasatch Clinical Research

Salt Lake City, Utah, United States

University of Utah Healthcare Health Sciences Center

Salt Lake City, Utah, United States

Tidewater Physicians for Women

Norfolk, Virginia, United States

Eastern Virginia Medical

Norfolk, Virginia, United States

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

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39581486 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CMDOC-0042

Identifier Type: -

Identifier Source: org_study_id