Evaluation of the Efficacy and Safety of LevoCept

Contraception Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Contraception

• NCT number: NCT02882191
• Study type: Interventional
• Source: Sebela Pharmaceuticals Inc.
• Status: Completed
• Phase: Phase 2
• Start date: November 2016
• Completion date: November 12, 2020