NCT00620035

A Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator (34530)(P05702)

An Open-Label, Non-Controlled Multicenter Trial to Evaluate the Insertion Characteristics of the Radiopaque Etonogestrel Implant Using a Next Generation Applicator

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to evaluate the use of the next generation applicator and its instructions for proper insertion of the Radiopaque Implant. Secondary objectives include: evaluation of implant removal, evaluation of the overall contraceptive efficacy and safety of the Radiopaque Implant, assessment of x -ray visibility of the Radiopaque Implant, and to assess participant expectations and satisfaction with the Radiopaque Implant.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Radiopaque Etonogestrel Implant	One implant inserted for a 3-year treatment period

Timeline

• Start date: 2007-03-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-02-21
• Last updated: 2022-02-04
• Results posted: 2011-10-31