Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

NCT04457076 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CMDOC-0062
• Study Type: interventional
• Target: 1,525
• Locations: 1 country
• Sites: 27

Brief Summary

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

Conditions

Contraception; Women at Risk for Pregnancy

Keywords

Contraception; IUD

Outcome Measures

Primary Outcomes (1)

• Contraceptive efficacy through 3 years of use as calculated by the Pearl Index

  through 3 years of use

Secondary Outcomes (11)

• 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

  Day 1 / LevoCept placement

• LevoCept Placement success

  Day 1 / LevoCept placement

• Incidence of AEs and SAEs

  5 years

Study Arms (1)

LevoCept

EXPERIMENTAL

LevoCept™ Intrauterine Contraceptive

Drug: LevoCept

Interventions

LevoCept DRUG

Levonorgestrel-Releasing Intrauterine System

LevoCept

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• 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 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;
• 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

You may not qualify if:

• 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;
• 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:

Sponsors & Collaborators

• Sebela Women's Health Inc.: lead
• PRA Health Sciences: collaborator

Study Sites (27)

Essential Access Health-Berkeley

Berkeley, California, 94710, United States

Location

Essential Access Health-Los Angeles

Los Angeles, California, 90010, United States

Location

University of California Davis Health System Department of Obstetrics and Gynecology

Sacramento, California, 95817, United States

Location

WR-Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Women's Health Care Research

San Diego, California, 92111, United States

Location

Stanford University, Medical Center, Obstetrics and Gynecolocy

Stanford, California, 94305, United States

Location

University Of Colorado Department of Obstetrics & Gyncology

Aurora, Colorado, 80045, United States

Location

Emory University School of Medicine Gynecology/Obstetrics

Atlanta, Georgia, 30308, United States

Location

Soapstone Center for Clinical Research

Decatur, Georgia, 30034, United States

Location

University of Hawaii

Honolulu, Hawaii, 96826, United States

Location

IU Health University Hospital

Indianapolis, Indiana, 46202, United States

Location

Planned Parenthood North Central States

Minneapolis, Minnesota, 55408, United States

Location

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

Columbia University Medical Center

New York, New York, 10032, United States

Location

University of Cincinnati/Reproductive Medicine Research

Cincinnati, Ohio, 45267, United States

Location

Ohio State University

Columbus, Ohio, 43209, United States

Location

The Ohio State University Ob/Gyn Research Office

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Research of Philadelphia, LLC

Philadelphia, Pennsylvania, 19114, United States

Location

Magee-Womens Hospital, Center for Family Planning Research

Pittsburgh, Pennsylvania, 15213, United States

Location

Advances In Health

Houston, Texas, 77030, 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 Women's: Health, Research, Gynecology

Seattle, Washington, 98105, United States

Location

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: LevoCept Intrauterine Device (IUD)

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: July 7, 2020
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): June 1, 2032
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)