Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00225186
First received: September 22, 2005
Last updated: January 9, 2013
Last verified: January 2013
| Tracking Information | |||||
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| First Received Date ICMJE | September 22, 2005 | ||||
| Last Updated Date | January 9, 2013 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety assessment of the drug [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Safety | ||||
| Change History | Complete list of historical versions of study NCT00225186 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Efficacy (reduction of pelvic pain) [ Time Frame: 12-18 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Efficacy (reduction of pelvic pain) | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Efficacy of SH T00660AA in Treatment of Endometriosis | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Endometriosis | ||||
| Intervention ICMJE | Drug: Visanne (SH T00660AA , BAY86-5258)
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients |
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| Study Arm (s) | Experimental: Arm 1
Intervention: Drug: Visanne (SH T00660AA , BAY86-5258) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 168 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 45 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany, Italy, Ukraine | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00225186 | ||||
| Other Study ID Numbers ICMJE | 91234, 307059 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Therapeutic Area Head, Bayer Healthcare AG | ||||
| Study Sponsor ICMJE | Bayer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Bayer | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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