Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

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. Identifier: NCT00225186
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : January 9, 2014
Information provided by (Responsible Party):

September 22, 2005
September 23, 2005
January 9, 2014
July 2004
March 2008   (Final data collection date for primary outcome measure)
Safety assessment of the drug [ Time Frame: 12-18 months ]
Complete list of historical versions of study NCT00225186 on Archive Site
Efficacy (reduction of pelvic pain) [ Time Frame: 12-18 months ]
Efficacy (reduction of pelvic pain)
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Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
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)
The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis
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.
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Visanne (SH T00660AA , BAY86-5258)
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients
Experimental: Arm 1
Intervention: Drug: Visanne (SH T00660AA , BAY86-5258)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2008
March 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Ukraine
307059 ( Other Identifier: company internal )
Not Provided
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Study Director: Bayer Study Director Bayer
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP