Evaluation of Efficacy, Safety and Tolerability of VeraCept IUD

Women at Risk for Pregnancy Clinical Trial

Official title: 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

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Women at Risk for Pregnancy

• NCT number: NCT03633799
• Study type: Interventional
• Source: Sebela Pharmaceuticals Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 22, 2018
• Completion date: September 22, 2027