A Phase 3, Prospective, Multi-Center, Single-Arm, Open-Label Study to Evaluate LevoCept™, a Long-Acting Reversible Intrauterine System for Contraceptive Efficacy, Safety, and Tolerability
Sebela Women's Health Inc.
Summary
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
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 1,525 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.
Eligibility
- Age range
- Up to 45 years
- Sex
- Female
- Healthy volunteers