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Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225186
First Posted: September 23, 2005
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis

Condition Intervention Phase
Endometriosis Drug: Visanne (SH T00660AA , BAY86-5258) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety assessment of the drug [ Time Frame: 12-18 months ]

Secondary Outcome Measures:
  • Efficacy (reduction of pelvic pain) [ Time Frame: 12-18 months ]

Enrollment: 168
Study Start Date: July 2004
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Visanne (SH T00660AA , BAY86-5258)
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225186


Locations
Germany
Heidelberg, Baden-Württemberg, Germany, 69115
Tuebingen, Baden-Württemberg, Germany, 72076
Krumbach, Bayern, Germany, 86381
München, Bayern, Germany, 81241
Nuernberg, Bayern, Germany, 90419
Giessen, Hessen, Germany, 35392
Mühlheim, Hessen, Germany, 63165
Aachen, Nordrhein-Westfalen, Germany, 52074
Gevelsberg, Nordrhein-Westfalen, Germany, 58285
Münster, Nordrhein-Westfalen, Germany, 48129
Kalbe, Sachsen-Anhalt, Germany, 39624
Dippoldiswalde, Sachsen, Germany, 01744
Leipzig, Sachsen, Germany, 04103
Marienberg, Sachsen, Germany, 09496
Weißig, Sachsen, Germany, 01474
Lübeck, Schleswig-Holstein, Germany, 23538
Greifswald, Germany, 17487
Italy
Brescia, Italy, 25123
Cagliari, Italy, 09042
Napoli, Italy, 80138
Roma, Italy, 00165
Torino, Italy, 10127
Ukraine
Chernivtsi, Ukraine, 58017
Kiev, Ukraine, 01030
Kiev, Ukraine, 04050
Kiev, Ukraine, 04107
Kiev, Ukraine, 04210
Vinnitsa, Ukraine, 21000
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00225186     History of Changes
Other Study ID Numbers: 91234
307059 ( Other Identifier: company internal )
First Submitted: September 22, 2005
First Posted: September 23, 2005
Last Update Posted: January 9, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female