NCT04457076

Evaluation of the Efficacy, Safety, and Tolerability of LevoCept

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,525 (estimated)
• 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 LevoCept

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.

Conditions

• Contraception
• Women at Risk for Pregnancy

Interventions

Type	Name	Description
DRUG	LevoCept	Levonorgestrel-Releasing Intrauterine System

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-06-01
• Completion: 2032-06-01
• First posted: 2020-07-07
• Last updated: 2025-05-22

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study