Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS

Running, not enrolling · Phase 3

Conditions studied: Women at Risk for Pregnancy

In brief

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

Key facts

Study ID

NCT03633799

Run by

Sebela Women's Health Inc.

People needed

1620

Starts

2018-08-22

Expected to finish

2027-09-22

Last updated by the study team

2025-08-22

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;
• 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;
• 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

You may not qualify if…

• 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;
• 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;

Where it is running

• MomDoc Women's Health Research — Scottsdale, Arizona, United States
• Copperstate OB/GYN Associates — Tucson, Arizona, United States
• Essential Access Health — Berkeley, California, United States
• Essential Access Health — Los Angeles, California, United States
• Empire Clinical Research — Pomona, California, United States
• University of California, Davis Health System — Sacramento, California, United States
• M3 Wake Research (formerly Women's Health Care Research) — San Diego, California, United States
• M3 Wake Research (formerly Medical Center for Clinical Research) — San Diego, California, United States
• Stanford University, Medical Center, Obstetrics and Gynecolocy — Stanford, California, United States
• Velocity Clinical Research (formerly Downtown Women's Health Care) — Englewood, Colorado, United States
• Altus Research, Inc — Lake Worth, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Soapstone Center for Clinical Research — Decatur, Georgia, United States
• Clinical Research Prime — Idaho Falls, Idaho, United States
• Women's Health Advantage — Fort Wayne, Indiana, United States
• Indiana University — Indianapolis, Indiana, United States
• Praetorian Pharmaceutical Research — Marrero, Louisiana, United States
• University of Michigan Von Voigtlander Women's Hospital — Ann Arbor, Michigan, United States
• Planned Parenthood North Central States - Minneapolis — Minneapolis, Minnesota, United States
• Planned Parenthood Great Rivers (formerly Planned Parenthood of the St. Louis Region and Southwest Missouri) — Manchester, Missouri, United States
• Rex Garn Mabey Jr., MD — Las Vegas, Nevada, United States
• Capital Health Lawrence OBGYN Research (formerly Lawrence OB/Gyn Clinical Research) — Lawrenceville, New Jersey, United States
• Columbia University Medical Center, Division of Family Planning — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati/Reproductive Medicine Research — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.