Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
Primary Purpose
Endometriosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Visanne (SH T00660AA , BAY86-5258)
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 or need for primary surgical treatment Any other conditions which forbid the participation
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Safety assessment of the drug
Secondary Outcome Measures
Efficacy (reduction of pelvic pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00225186
Brief Title
Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
Official Title
A Multi-center, Open, One-arm Study to Investigate the Safety and Efficacy of Daily Oral Administration of T00660AA for the Treatment of Endometriosis Over 52 Weeks (Follow-up to Study 307041)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Visanne (SH T00660AA , BAY86-5258)
Intervention Description
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
Primary Outcome Measure Information:
Title
Safety assessment of the drug
Time Frame
12-18 months
Secondary Outcome Measure Information:
Title
Efficacy (reduction of pelvic pain)
Time Frame
12-18 months
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 or 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
Facility Information:
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69115
Country
Germany
City
Tuebingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
City
Krumbach
State/Province
Bayern
ZIP/Postal Code
86381
Country
Germany
City
München
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
City
Mühlheim
State/Province
Hessen
ZIP/Postal Code
63165
Country
Germany
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
City
Gevelsberg
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58285
Country
Germany
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48129
Country
Germany
City
Kalbe
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39624
Country
Germany
City
Dippoldiswalde
State/Province
Sachsen
ZIP/Postal Code
01744
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Marienberg
State/Province
Sachsen
ZIP/Postal Code
09496
Country
Germany
City
Weißig
State/Province
Sachsen
ZIP/Postal Code
01474
Country
Germany
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
City
Greifswald
ZIP/Postal Code
17487
Country
Germany
City
Brescia
ZIP/Postal Code
25123
Country
Italy
City
Cagliari
ZIP/Postal Code
09042
Country
Italy
City
Napoli
ZIP/Postal Code
80138
Country
Italy
City
Roma
ZIP/Postal Code
00165
Country
Italy
City
Torino
ZIP/Postal Code
10127
Country
Italy
City
Chernivtsi
ZIP/Postal Code
58017
Country
Ukraine
City
Kiev
ZIP/Postal Code
01030
Country
Ukraine
City
Kiev
ZIP/Postal Code
04050
Country
Ukraine
City
Kiev
ZIP/Postal Code
04107
Country
Ukraine
City
Kiev
ZIP/Postal Code
04210
Country
Ukraine
City
Vinnitsa
ZIP/Postal Code
21000
Country
Ukraine
12. IPD Sharing Statement
Citations:
PubMed Identifier
20444534
Citation
Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejogrb.2010.04.002. Epub 2010 May 5.
Results Reference
result
PubMed Identifier
19819448
Citation
Kohler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010 Jan;108(1):21-5. doi: 10.1016/j.ijgo.2009.08.020. Erratum In: Int J Gynaecol Obstet. 2011 Mar;112(3):257.
Results Reference
result
PubMed Identifier
21106059
Citation
Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138.
Results Reference
result
PubMed Identifier
21681516
Citation
Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T. Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1941-7. Epub 2011 Jun 17.
Results Reference
result
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Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
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