NCT02882191

Evaluation of the Efficacy and Safety of LevoCept

Evaluation of the Effectiveness, Safety and Tolerability of LevoCept (Levonorgestrel-Releasing Intrauterine System) for Long-Acting Reversible Contraception

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (actual)
• Sponsor: Sebela Women's Health Inc. · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effectiveness, device placement, safety, and tolerability of LevoCept to support commencing a Phase III Clinical Study

Detailed description

Study Design: Prospective, multi-center, single-arm, open-label, Phase II clinical study Approximately 250 subjects will be enrolled at about 14 centers in the US. Study Population: Pre-menopausal women ages 18 - 40, at risk for pregnancy, who are interested in using only this intrauterine contraceptive for birth control will be eligible for this study. Subjects must provide written informed consent and meet the study subject selection criteria without any exclusions as outlined in the Clinical Investigation Plan (CIP). Primary Effectiveness Outcome: The primary outcome measure is effectiveness, evaluated as the absence of pregnancy during LevoCept use. Safety and other outcome measures include: Study Device Placement: * Ease of placement * Placement success Safety: * Serious Adverse Events * Adverse Events Tolerability: * Bleeding and spotting patterns * Discontinuation rate and reasons for discontinuation

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	LevoCept	placement of LevoCept IUD

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-07-17
• Completion: 2020-11-12
• First posted: 2016-08-29
• Last updated: 2022-04-12

Locations

16 sites across 1 country: United States