Back to resultsEfficacy and Safety of SH T00660AA in Treatment of Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Visanne (BAY86-5258, SH T00660AA)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Adverse event collection
Treatment satisfaction by patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00225199
Brief Title
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Oral Administration of SH T00660AA for the Treatment of Endometriosis Over 12 Weeks
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Visanne (BAY86-5258, SH T00660AA)
Intervention Description
orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
orally once daily
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
Assessment of pain relief at end of treatment
Secondary Outcome Measure Information:
Title
Adverse event collection
Time Frame
Assessment at end of study
Title
Treatment satisfaction by patient
Time Frame
Assessment at end of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis
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