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

Phase 2 Completed 84 enrolled Organon and Co

RandomizedParallel-groupSingle-blindPrevention

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®.

Timeline

Start: 2009-11
Primary completion: 2010-11
Completion: 2011-07

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etonogestrel	Unknown	38 mg	Other
Subject	Etonogestrel	Unknown	61 mg	Other
Subject	Etonogestrel	Unknown	72 mg	Other

Indications

No indication recorded.