Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Phase 3

Completed

• Conditions: Endometriosis
• Interventions: Drug: Visanne (SH T00660AA , BAY86-5258)

• Registration Number: NCT00225186
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis

Detailed Description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-23
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-08
• Last Update Posted: 2014-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

• Female patients with endometriosis-associated pelvic pain

Exclusion Criteria

• Pregnant or lactating women
• History or suspicion of hormone dependent tumor
• Therapy resistant endometriosis or need for primary surgical treatment
• Any other conditions which forbid the participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Visanne (SH T00660AA , BAY86-5258)	-

Primary Outcome Measures

Name	Time	Method
Safety assessment of the drug	12-18 months

Secondary Outcome Measures

Name	Time	Method
Efficacy (reduction of pelvic pain)	12-18 months