Last updated on July 2020

Evaluation of Efficacy Safety and Tolerability of VeraCept IUD

Brief description of study

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

Detailed Study 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 1,605 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.

Primary Endpoint:

The primary endpoint is the contraceptive efficacy through 3 years of use, as assessed by the Pearl Index.

Secondary endpoints:

Contraceptive Efficacy:

  • Pearl Index at Years 4 and 5, as well as cumulatively through Years 4 and 5.
  • Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4 and 5

Study drug placement:

  • Ease of VeraCept placement
  • Placement success
  • Serious adverse events (SAEs)
  • Adverse events (AEs)
  • Pelvic infection (pelvic inflammatory disease (PID) or endometritis)
  • Ectopic pregnancies
  • Uterine perforations
  • Dysmenorrhea
  • Abdominal pain
  • Expulsion rates at Years 1, 2, 3, 4 and 5
  • Bleeding and spotting patterns
  • Insertion pain assessed immediately after insertion
  • Continuation rates at Years 1, 2, 3, 4 and 5
  • Reasons for discontinuation Return to fertility
  • Pregnancy rate in subjects who request VeraCept removal specifically to become pregnant. Subjects who desire pregnancy after having VeraCept removed will be followed for either 1 year, until they decide to no longer try to conceive or they become pregnant, whichever comes first.

Clinical Study Identifier: NCT03633799

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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