AzTrials
AzTrials

Women at Risk for PregnancyPhase 3NCT03633799

Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS

A Phase 3 study testing VeraCept in people with Women at Risk for Pregnancy, run by Sebela Women's Health Inc. at 41 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

To assess the contraceptive efficacy (prevention of pregnancy) of VeraCept 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,620 participants
Where
41 sitesUnited States
Study dates
22 Aug 2018to 22 Sep 2027
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;
Show all 13Show fewer
  • 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

Who cannot join

  • 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;
Show all 30Show fewer
  • 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
  • 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 IUS;
  • 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;
  • Untreated or unresolved acute cervicitis or vaginitis;
  • 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 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 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);
  • 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.
  • Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • University of Michigan Von Voigtlander Women's Hospital

    Ann Arbor, Michigan, 48109

  • Emory University School of Medicine

    Atlanta, Georgia, 30308

  • Essential Access Health

    Berkeley, California, 94710

  • Medical Research South, LLC

    Charleston, South Carolina, 29407

  • Chattanooga Medical Research

    Chattanooga, Tennessee, 37404

  • University of Cincinnati/Reproductive Medicine Research

    Cincinnati, Ohio, 45267

  • The Ohio State University Ob/Gyn Research Office

    Columbus, Ohio, 43210

  • Advanced Research Associates

    Corpus Christi, Texas, 78414

  • Soapstone Center for Clinical Research

    Decatur, Georgia, 30034

  • Duke University Medical Center

    Durham, North Carolina, 27710

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

    Englewood, Colorado, 80110

  • Women's Health Advantage

    Fort Wayne, Indiana, 46825

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Indiana University

    Indianapolis, Indiana, 46202

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • Altus Research, Inc

    Lake Worth, Florida, 33461

  • Rex Garn Mabey Jr., MD

    Las Vegas, Nevada, 89128

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

    Lawrenceville, New Jersey, 08648

  • Essential Access Health

    Los Angeles, California, 90010

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

    Manchester, Missouri, 63088

  • Praetorian Pharmaceutical Research

    Marrero, Louisiana, 70072

  • Planned Parenthood North Central States - Minneapolis

    Minneapolis, Minnesota, 55408

  • Columbia University Medical Center, Division of Family Planning

    New York, New York, 10032

  • Tidewater Physicians for Women

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical

    Norfolk, Virginia, 23507

  • Advances In Health

    Pearland, Texas, 77584

  • University of Pennsylvania/Penn Family Planning and Pregnancy Loss Center

    Philadelphia, Pennsylvania, 19104

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Magee-Womens Hospital, Center for Family Planning Research

    Pittsburgh, Pennsylvania, 15213

  • Empire Clinical Research

    Pomona, California, 91767

  • OHSU Women's Health Research Unit

    Portland, Oregon, 97239

  • University of California, Davis Health System

    Sacramento, California, 95817

  • Wasatch Clinical Research

    Salt Lake City, Utah, 84107

  • University of Utah Healthcare Health Sciences Center

    Salt Lake City, Utah, 84132

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

    San Diego, California, 92111

  • M3 Wake Research (formerly Medical Center for Clinical Research)

    San Diego, California, 92120

  • MomDoc Women's Health Research

    Scottsdale, Arizona, 85251

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

    Seattle, Washington, 98104

  • University of Washington Medical Center

    Seattle, Washington, 98117

  • Stanford University, Medical Center, Obstetrics and Gynecolocy

    Stanford, California, 94305

  • Copperstate OB/GYN Associates

    Tucson, Arizona, 85712

Other trials in United States

About this study

Official title: A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept®, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability

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

Read the 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.

Being tested
VeraCept

What participants receive

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

  • VeraCeptDrug

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

Study groups in NCT03633799
Study groupRoleWhat they receive
VeraCeptExperimentalVeraCept® Intrauterine Contraceptive
Receives: Drug: VeraCept

What is being measured

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

  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.

    Measured: 3 years

Secondary outcomes (10)

  1. Contraceptive Efficacy at Years 4, 5, 6, 7 and 8

    Pearl Index will be calculated for Years 4, 5, 6, 7, and 8 as well as cumulatively through Years 4, 5, 6, 7, and 8

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

  2. Cumulative Pregnancy Percentage

    A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage

    Measured: Years 1 through 3

  3. Ease of VeraCept Placement

    Ease of VeraCept placement will be summarized for the ITT population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard). (First Attempt)

    Measured: Visit 1 (Day 1) / VeraCept placement

  4. VeraCept Placement Success

    The number and percentage of subjects with either a successful or unsuccessful placement will be summarized for the ITT

    Measured: Visit 1 (Day 1) / VeraCept placement

  5. Bleeding and Spotting Patterns

    Bleeding and spotting patterns will be summarized for the first year of treatment by the number of days in each 28-day cycle with bleeding or spotting, bleeding only, and spotting only

    Measured: Through year 1

  6. Insertion Pain Assessed Immediately After Insertion (First Attempt)

    Insertion pain summarized for subjects at first attempt as reported by the subjects

    Measured: Visit 1 (Day 1), immediately after insertion

  7. Cumulative VeraCept Discontinuation Rates

    Cumulative VeraCept discontinuation rates will be summarized using Kaplan-Meier methods for the Safety population.

    Measured: Years 1 through 3

  8. Cumulative VeraCept Expulsion Rates

    Cumulative VeraCept expulsion rates will be summarized using Kaplan-Meier methods for the Safety population.

    Measured: Years 1 through 3

  9. Return to Fertility. Only for Subjects Requesting VeraCept Removal to Become Pregnant.

    The number and percentage of subjects with each return to fertility response will be summarized for the Safety population.

    Measured: Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.

  10. Safety Adverse Events of Special Interest: Pelvic Infection (PID or Endometriosis), Uterine Perforations, and Abdominal Pain

    Measured: 3 years

Timeline

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

  1. First posted16 Aug 2018
  2. Study start22 Aug 2018
  3. Primary completion22 Sep 2022
  4. Study completion22 Sep 2027 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
VeraCept Intrauterine System (IUS)
Masking
None (open label)
Enrolment
1,620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03633799
Sponsor's protocol ID
CMDOC-0042
Status last verified
Aug 2025
First submitted
19 Jul 2018
Last updated
22 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gawron LM, Roe AH, Nelson AL, Bernard C, Castano PM, Cwiak C, Schreifels MJ, Peters K, Culwell KR, Gray E, Turok DK; on behalf of the Copper 175 mm IUD Phase 3 Clinical Investigator Group. Five-Year Phase 3 Efficacy and Safety Outcomes With a Low-Dose Copper Intrauterine Device. Obstet Gynecol. 2026 May 1;147(5):699-707. doi: 10.1097/AOG.0000000000006227. Epub 2026 Feb 26.

    PubMed 41747268

  • 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.

    PubMed 39581486

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VeraCept in people with Women at Risk for Pregnancy, run by Sebela Women's Health Inc. at 41 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 30 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: under way, not looking for participants, as of the sponsor's last update on 22 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 41 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 22 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?

Contraceptive Efficacy Through 3 Years of Use (time frame: 3 years). 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 NCT03633799, which also lists 2 linked publications.

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 22 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in