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ContraceptionPhase 3NCT04457076

Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

A Phase 3 study testing LevoCept in people with Contraception and Women at Risk for Pregnancy, run by Sebela Women's Health Inc. at 27 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept 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
Contraception, Women at Risk for Pregnancy
What is being tested?
LevoCept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,525 participants
Where
27 sitesUnited States
Study dates
1 Jun 2026to 1 Jun 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 nor other known fertility problems;
  • Reasonably expect to have coitus at least once monthly during the study period;
  • In a mutually monogamous relationship of at least 3 months duration at time of consent;
  • 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 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 to 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 must have a normal Pap test or an ASC-US result with a negative high-risk human papilloma virus (HPV) test result within the appropriate screen timeframe per 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 (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/legal guardian consent documented on the consent form consistent with local legal requirements;
  • Plan to reside within a reasonable travel distance of a research site for the duration of the study.
  • Subject agrees not to intentionally self-remove LevoCept

Who cannot join

  • Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle;
  • Has had any procedure for or causing sterility (e.g. tubal ligation procedure);
  • Subject who anticipates separation from her partner for more than a 6-month period during use of LevoCept;
  • A previously inserted IUD/IUS that has not been removed by the time the study IUS is placed;
  • History of previous IUD/IUS complications, such as perforation, expulsion, or pregnancy with IUD/IUS in place;
  • Pain with current IUD/IUS;
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  • 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;
  • Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)
  • 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 test 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 breast cancer or other progestin-sensitive cancer now or in the past;
  • Known acute liver disease or liver tumor;
  • Subjects who have an established immunodeficiency;
  • Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
  • At high risk for sexually transmitted infections (e.g. multiple sexual partners);
  • Known intolerance or allergy to any components of LevoCept, including intolerance or allergy to levonorgestrel, nickel, titanium, or silicone;
  • 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 previously been enrolled in a VeraCept or LevoCept study (including the current 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.

Trial locations and contacts

27 sites in 1 country. Contact the study team or a site near you to ask about taking part.

27 sites in 1 country

United States27 sites

  • Emory University School of Medicine Gynecology/Obstetrics

    Atlanta, Georgia, 30308

    Valerie Jean, 404-778-1373, familyplanning@emory.edu

    Tiffany Hailstorks, MD

  • University Of Colorado Department of Obstetrics & Gyncology

    Aurora, Colorado, 80045

  • Essential Access Health-Berkeley

    Berkeley, California, 94710

    Amber Van Kessel, 213-386-5614 ext. 2205, avankessel@essentialaccess.org

    Jade Aganus, 213-386-5614 ext. 2205, aaganus@essentialaccess.org

  • University of Cincinnati/Reproductive Medicine Research

    Cincinnati, Ohio, 45267

  • Ohio State University

    Columbus, Ohio, 43209

  • The Ohio State University Ob/Gyn Research Office

    Columbus, Ohio, 43210

  • Soapstone Center for Clinical Research

    Decatur, Georgia, 30034

    Natalie Hinton, 404-534-9359, nhinton4sccr@aol.com

    Sarah Holmes, 404-534-9359, sholmes4sccr@aol.com

  • University of Hawaii

    Honolulu, Hawaii, 96826

    Emory Bowen, 808-203-6574, ebowen@ucera.org

    Jasmine Tyson, 808-203-6594, jasminetyson@ucera.org

  • Advances In Health

    Houston, Texas, 77030

  • IU Health University Hospital

    Indianapolis, Indiana, 46202

    Kathleen Wendholt, 317-948-0796, schmittk@iu.edu

    Morgan Runkel, 317-948-7587, mlrunkel@iu.edu

  • Rex Garn Mabey Jr., MD

    Las Vegas, Nevada, 89128

  • Essential Access Health-Los Angeles

    Los Angeles, California, 90010

    Seline Guidotti, 213-386-5614 ext. 4500, sguidotti@essentialaccess.org

    Anna Garcia, 213-386-5614 ext. 4596, agarcia@essentialaccess.org

  • Planned Parenthood of the St. Louis Region and Southwest Missouri

    Manchester, Missouri, 63088

  • Planned Parenthood North Central States

    Minneapolis, Minnesota, 55408

    Bridge McKye, 651-389-0675, bmckye@ppncs.org

    Marcy Thomas, 651-237-4046, mthomas@ppncs.org

  • Columbia University Medical Center

    New York, New York, 10032

  • Tidewater Physicians for Women

    Norfolk, Virginia, 23502

  • Eastern Virginia Medical

    Norfolk, Virginia, 23507

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Clinical Research of Philadelphia, LLC

    Philadelphia, Pennsylvania, 19114

  • Magee-Womens Hospital, Center for Family Planning Research

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of California Davis Health System Department of Obstetrics and Gynecology

    Sacramento, California, 95817

    UC Davis ObGyn Research, 916-734-6846, hs-obgynresearch@ucdavis.edu

    Mitchell Creinin, MD

  • University of Utah Healthcare Health Sciences Center

    Salt Lake City, Utah, 84132

  • WR-Medical Center for Clinical Research

    San Diego, California, 92108

    Merrilee Fleet, 919-645-9225, mfleet@wakeresearch.com

    Jessica Backus, 858-987-2219, jbackus@mccresearch.com

  • Women's Health Care Research

    San Diego, California, 92111

    Rovena Reagan, MD, 858-505-8672, information@whcresearch.com

    Rovena Reagan, MD

  • Seattle Women's: Health, Research, Gynecology

    Seattle, Washington, 98105

  • Stanford University, Medical Center, Obstetrics and Gynecolocy

    Stanford, California, 94305

    Tayler Hughes, 650-721-1237, birthcontrol@stanford.edu

    Kathryn Bathem, 650-724-7826, gynresearch@stanford.edu

Other trials in United States

About this study

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

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

Read the detailed description

Study Design:

Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 5 years

Number of Subjects:

Approximately 1,525 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.

Being tested
LevoCept
Keywords
Contraception, IUD

What participants receive

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

  • LevoCeptDrug

    Levonorgestrel-Releasing Intrauterine System

Study groups in NCT04457076
Study groupRoleWhat they receive
LevoCeptExperimentalLevoCept™ Intrauterine Contraceptive
Receives: Drug: LevoCept

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 as calculated by the Pearl Index

    Measured: through 3 years of use

Secondary outcomes (11)

  1. Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index

    Measured: Years 4 and 5 and cumulatively through Years 4 and 5

  2. Pregnancy percentage

    Measured: Years 1 through 5

  3. Ease of LevoCept placement

    Ease of LevoCept placement will be summarized for the Safety population as reported by the investigator (Very easy, Easy, Neither Easy nor Hard, Hard, Very Hard).

    Measured: Day 1 / LevoCept placement

  4. LevoCept Placement success

    The number of subjects with either a successful or unsuccessful placement will be summarized

    Measured: Day 1 / LevoCept placement

  5. Incidence of AEs and SAEs

    Measured: 5 years

  6. Bleeding and spotting patterns

    Measured: Through year 1

  7. Insertion pain assessed immediately after insertion

    Summarized for subjects with and without prior prophylactic pain medication as measured by an 11-Point Numeric Pain Rating Scale. The scale being 0 - 10 with 0 being no pain and 10 being the worse pain

    Measured: Day 1, immediately after insertion

  8. Cumulative LevoCept continuation rates

    Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.

    Measured: Years 1 through 5

  9. Cumulative LevoCept expulsion rates

    Measured: Years 1 through 5

  10. Return to Fertility. Only for subjects requesting LevoCept removal to become pregnant.

    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.

  11. Release rate of LNG from the IUS and resulting pharmacokinetics of LNG (PK substudy)

    Measured: Years 1 through 5

Timeline

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

  1. First posted7 Jul 2020
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2032 (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
LevoCept Intrauterine Device (IUD)
Masking
None (open label)
Enrolment
1,525 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04457076
Sponsor's protocol ID
CMDOC-0062
Status last verified
May 2025
First submitted
11 Jun 2020
Last updated
22 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LevoCept in people with Contraception and Women at Risk for Pregnancy, run by Sebela Women's Health Inc. at 27 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 34 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: opening soon, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contraceptive efficacy through 3 years of use as calculated by the Pearl Index (time frame: through 3 years of use). 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 NCT04457076.

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 May 2025.

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