NCT00967746

An Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Etonogestrel-releasing Medicated Intrauterine Systems (Study P06060)

A Randomized, Multicenter, Explorative Trial to Explore the Safety, Acceptability and Vaginal Bleeding Pattern of Three Doses of an Etonogestrel-releasing Medicated Intrauterine System (ENG-MIUS) Versus a Copper-releasing Intrauterine Device (IUD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Organon and Co · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This is a phase 2, randomized, active-controlled, parallel-group, multicenter, single-blind trial of three different doses of etonogestrel releasing medicated intrauterine systems (ENG-MIUS) in healthy parous women in need for contraception. The primary trial objective is to explore safety and acceptability of three doses of an ENG-releasing medicated intrauterine system (ENG-MIUS) as compared to Multiload-cu 375®.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Etonogestrel-releasing IUS	Low dose; treatment duration of 6 months with a possible extension to 12 months
DRUG	Etonogestrel-releasing IUS	Intermediate dose; treatment duration of 6 months with a possible extension to 12 months
DRUG	Etonogestrel-releasing IUS	High dose; treatment duration of 6 months with a possible extension to 12 months
DEVICE	Multiload-cu 375®	Duration of 6 months with a possible extension to 12 months

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-11-01
• Completion: 2011-07-01
• First posted: 2009-08-28
• Last updated: 2026-04-08

Locations

1 site across 1 country: Germany