Efficacy and Safety of SH T00660AA in Treatment of Endometriosis

Phase 3

Completed

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

• Registration Number: NCT00225199
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to placebo in 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: 2004-03
• Study First Submitted: 2005-09-22
• Study First Submitted QC: 2005-09-22
• Study First Posted: 2005-09-23
• Study Completion: 2006-09
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-22
• Last Update Posted: 2010-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 198

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
• need for primary surgical treatment
• any other conditions which forbid the participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Visanne (BAY86-5258, SH T00660AA)	-
Arm 2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Efficacy	Assessment of pain relief at end of treatment

Secondary Outcome Measures

Name	Time	Method
Adverse event collection	Assessment at end of study
Treatment satisfaction by patient	Assessment at end of study