NCT03633799

Evaluation of Efficacy, Safety and Tolerability of VeraCept IUS

A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate VeraCept®, a Long-Acting Reversible Intrauterine Contraceptive for Contraceptive Efficacy, Safety, and Tolerability

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,620 (actual)
• Sponsor: Sebela Women's Health Inc. · Industry
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Study Design: Prospective, multi-center, single-arm, open-label, Phase 3 clinical study to 3 years with extension up to 8 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, 5, 6, 7 and 8 as well as cumulatively through Years 4, 5, 6, 7 and 8. * Pregnancy percentage by life table analysis (Kaplan-Meier) at Years 1, 2, 3, 4, 5, 6, 7 and 8 * The cumulative Pearl Index for Years 6 to 8 will be calculated as well as the cumulative pregnancy percentage for Years 6 to 8 using a life table analysis (Kaplan-Meier) only for the EP population. Study drug placement: * Ease of VeraCept placement * Placement success Safety: * 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, 5, 6, 7 and 8 Tolerability: * Bleeding and spotting patterns * Insertion pain assessed immediately after insertion * Continuation rates at Years 1, 2, 3, 4, 5, 6, 7 and 8 * 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.

Conditions

• Women at Risk for Pregnancy

Interventions

Type	Name	Description
DRUG	VeraCept	VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method

Timeline

• Start date: 2018-08-22
• Primary completion: 2022-09-22
• Completion: 2027-09-22
• First posted: 2018-08-16
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study