clinical trial · NCT04457076
Evaluation of the Efficacy, Safety, and Tolerability of LevoCept
Sebela Women's Health Inc.·phase3·not yet recruiting·n = 1,525
ContraceptionWomen at Risk for PregnancyLevoCept
brief summary
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
started
Jun 1, 2026
primary completion
Jun 1, 2030
completion
Jun 1, 2032
last updated
May 22, 2025
detailed 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.
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol