Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00225186
First received: September 22, 2005
Last updated: January 8, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy (reduction of pelvic pain) [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 04050
Kiev, Ukraine, 04107
Kiev, Ukraine, 04210
Kiev, Ukraine, 01030
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
Study First Received: September 22, 2005
Last Updated: January 8, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 24, 2014