Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

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

Study Overview

• Status: Not yet recruiting
• Conditions: Contraception; Women at Risk for Pregnancy
• Intervention / Treatment: Drug: LevoCept

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.

• Study Type: Interventional
• Enrollment (Estimated): 1525
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94710
      • Essential Access Health-Berkeley
      • Contact: Amber Van Kessel; Phone Number: 2205 213-386-5614; Email: avankessel@essentialaccess.org
      • Contact: Jade Aganus; Phone Number: 2205 213-386-5614; Email: aaganus@essentialaccess.org
      • Principal Investigator: Fung Lam, MD
    • Los Angeles, California, United States, 90010
      • Essential Access Health-Los Angeles
      • Contact: Seline Guidotti; Phone Number: 4500 213-386-5614; Email: sguidotti@essentialaccess.org
      • Contact: Anna Garcia; Phone Number: 4596 213-386-5614; Email: agarcia@essentialaccess.org
      • Principal Investigator: Anita Nelson, MD
    • Sacramento, California, United States, 95817
      • University of California Davis Health System Department of Obstetrics and Gynecology
      • Principal Investigator: Mitchell Creinin, MD
      • Contact: UC Davis ObGyn Research; Phone Number: 916-734-6846; Email: hs-obgynresearch@ucdavis.edu
    • San Diego, California, United States, 92108
      • WR-Medical Center For Clinical Research
      • Principal Investigator: Denis Tarakjian, MD
      • Contact: Merrilee Fleet; Phone Number: 919-645-9225; Email: mfleet@wakeresearch.com
      • Contact: Jessica Backus; Phone Number: 858-987-2219; Email: jbackus@mccresearch.com
    • San Diego, California, United States, 92111
      • Women's Health Care Research
      • Principal Investigator: Rovena Reagan, MD
      • Contact: Rovena Reagan, MD; Phone Number: 858-505-8672; Email: information@whcresearch.com
    • Stanford, California, United States, 94305
      • Stanford University, Medical Center, Obstetrics and Gynecolocy
      • Contact: Tayler Hughes; Phone Number: 650-721-1237; Email: birthcontrol@stanford.edu
      • Contact: Kathryn Bathem; Phone Number: 650-724-7826; Email: gynresearch@stanford.edu
      • Principal Investigator: Paul Blumenthal, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University Of Colorado Department of Obstetrics & Gyncology
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University School of Medicine Gynecology/Obstetrics
      • Contact: Valerie Jean; Phone Number: 404-778-1373; Email: familyplanning@emory.edu
      • Principal Investigator: Tiffany Hailstorks, MD
    • Decatur, Georgia, United States, 30034
      • Soapstone Center for Clinical Research
      • Contact: Natalie Hinton; Phone Number: 404-534-9359; Email: nhinton4sccr@aol.com
      • Contact: Sarah Holmes; Phone Number: 404-534-9359; Email: sholmes4sccr@aol.com
      • Principal Investigator: Sonya Marks, MD
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • University of Hawaii
      • Principal Investigator: Bliss Kaneshiro, MD
      • Contact: Emory Bowen; Phone Number: 808-203-6574; Email: ebowen@ucera.org
      • Contact: Jasmine Tyson; Phone Number: 808-203-6594; Email: jasminetyson@ucera.org
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health University Hospital
      • Contact: Kathleen Wendholt; Phone Number: 317-948-0796; Email: schmittk@iu.edu
      • Contact: Morgan Runkel; Phone Number: 317-948-7587; Email: mlrunkel@iu.edu
      • Principal Investigator: Jeffrey Peipert, MD, PhD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55408
      • Planned Parenthood North Central States
      • Contact: Bridge McKye; Phone Number: 651-389-0675; Email: bmckye@ppncs.org
      • Contact: Marcy Thomas; Phone Number: 651-237-4046; Email: mthomas@ppncs.org
      • Principal Investigator: Christy Boraas, MD
  • Missouri
    • Manchester, Missouri, United States, 63088
      • Planned Parenthood of the St. Louis Region and Southwest Missouri
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Rex Garn Mabey Jr., MD
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati/Reproductive Medicine Research
    • Columbus, Ohio, United States, 43209
      • Ohio State University
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Ob/Gyn Research Office
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia, LLC
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital, Center for Family Planning Research
  • Texas
    • Houston, Texas, United States, 77030
      • Advances in Health
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Healthcare Health Sciences Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Physicians for Women
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's: Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 nor other known fertility problems;
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 at time of consent;
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 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;
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/legal guardian consent documented on the consent form consistent with local legal requirements;
12. Plan to reside within a reasonable travel distance of a research site for the duration of the study.
13. Subject agrees not to intentionally self-remove LevoCept

Exclusion Criteria:

1. Known or suspected pregnancy; or at risk for pregnancy from unprotected intercourse earlier in current cycle;
2. Has had any procedure for or causing sterility (e.g. tubal ligation procedure);
3. Subject who anticipates separation from her partner for more than a 6-month period during use of LevoCept;
4. A previously inserted IUD/IUS that has not been removed by the time the study IUS is placed;
5. History of previous IUD/IUS complications, such as perforation, expulsion, or pregnancy with IUD/IUS in place;
6. Pain with current IUD/IUS;
7. 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;
8. Subject is <4 weeks post-pregnancy (postpartum, spontaneous or induced abortion)
9. Planned use of any non-contraceptive estrogen, progesterone or testosterone any time during the 60 months of study participation;
10. Exclusively breastfeeding before return of menses; lactating women will be excluded unless they have had 2 normal menstrual periods prior to enrollment;
11. Unexplained abnormal uterine bleeding (suspicious for a serious condition), including bleeding 4 weeks post-septic abortion or puerperal sepsis;
12. Severely heavy or painful menstrual bleeding;
13. Suspected or known cervical, uterine or ovarian cancer, or unresolved clinically significant abnormal Pap test requiring evaluation or treatment;
14. Any history of gestational trophoblastic disease with or without detectable elevated ß-human chorionic gonadotropin (ß-hCG) levels, or related malignant disease;

15. 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
16. 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;
17. 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;
18. Untreated or unresolved acute cervicitis or vaginitis;
19. Known or suspected breast cancer or other progestin-sensitive cancer now or in the past;
20. Known acute liver disease or liver tumor;
21. Subjects who have an established immunodeficiency;
22. Known or suspected human immunodeficiency virus (HIV) infection or clinical AIDS;
23. At high risk for sexually transmitted infections (e.g. multiple sexual partners);
24. Known intolerance or allergy to any components of LevoCept, including intolerance or allergy to levonorgestrel, nickel, titanium, or silicone;
25. 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;
26. Subject has previously been enrolled in a VeraCept or LevoCept study (including the current study);
27. Known or suspected alcohol or drug abuse within 12 months prior to the screening visit;
28. 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;
29. Study staff or a member of the immediate family of study staff.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LevoCept; LevoCept™ Intrauterine Contraceptive	Drug: LevoCept; Levonorgestrel-Releasing Intrauterine System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Contraceptive efficacy through 3 years of use as calculated by the Pearl Index	through 3 years of use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contraceptive efficacy at Years 4 and 5 as calculated by the Pearl Index		Years 4 and 5 and cumulatively through Years 4 and 5
Pregnancy percentage		Years 1 through 5
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).	Day 1 / LevoCept placement
LevoCept Placement success	The number of subjects with either a successful or unsuccessful placement will be summarized	Day 1 / LevoCept placement
Incidence of AEs and SAEs		5 years
Bleeding and spotting patterns		Through year 1
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	Day 1, immediately after insertion
Cumulative LevoCept continuation rates	Continuation rates at Years 1, 2, 3, 4 and 5, Reasons for discontinuation will be summarized.	Years 1 through 5
Cumulative LevoCept expulsion rates		Years 1 through 5
Return to Fertility. Only for subjects requesting LevoCept removal to become pregnant.		Subjects will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.
Release rate of LNG from the IUS and resulting pharmacokinetics of LNG (PK substudy)		Years 1 through 5

Collaborators and Investigators

• Sponsor: Sebela Women's Health Inc.
• Collaborators: PRA Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: June 11, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Contraception; IUD
• Other Study ID Numbers: CMDOC-0062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No