Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

Starting soon · Phase 3

Conditions studied: Contraception, Women at Risk for Pregnancy

In brief

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

Key facts

Study ID

NCT04457076

Run by

Sebela Women's Health Inc.

People needed

1525

Starts

2026-06-01

Expected to finish

2032-06-01

Last updated by the study team

2025-05-22

Who can join

Age: any, up to 45. Sex: female. Healthy volunteers: accepted.

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:
• 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;

Where it is running

• Essential Access Health-Berkeley — Berkeley, California, United States
• Essential Access Health-Los Angeles — Los Angeles, California, United States
• University of California Davis Health System Department of Obstetrics and Gynecology — Sacramento, California, United States
• WR-Medical Center for Clinical Research — San Diego, California, United States
• Women's Health Care Research — San Diego, California, United States
• Stanford University, Medical Center, Obstetrics and Gynecolocy — Stanford, California, United States
• University Of Colorado Department of Obstetrics & Gyncology — Aurora, Colorado, United States
• Emory University School of Medicine Gynecology/Obstetrics — Atlanta, Georgia, United States
• Soapstone Center for Clinical Research — Decatur, Georgia, United States
• University of Hawaii — Honolulu, Hawaii, United States
• IU Health University Hospital — Indianapolis, Indiana, United States
• Planned Parenthood North Central States — Minneapolis, Minnesota, United States
• Planned Parenthood of the St. Louis Region and Southwest Missouri — Manchester, Missouri, United States
• Rex Garn Mabey Jr., MD — Las Vegas, Nevada, United States
• Columbia University Medical Center — New York, New York, United States
• University of Cincinnati/Reproductive Medicine Research — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• The Ohio State University Ob/Gyn Research Office — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Clinical Research of Philadelphia, LLC — Philadelphia, Pennsylvania, United States
• Magee-Womens Hospital, Center for Family Planning Research — Pittsburgh, Pennsylvania, United States
• Advances In Health — Houston, Texas, United States
• University of Utah Healthcare Health Sciences Center — Salt Lake City, Utah, United States
• Tidewater Physicians for Women — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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