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

September 22, 2005
January 8, 2014
July 2004
March 2008   (final data collection date for primary outcome measure)
Safety assessment of the drug [ Time Frame: 12-18 months ] [ Designated as safety issue: Yes ]
Safety
Complete list of historical versions of study NCT00225186 on ClinicalTrials.gov Archive Site
Efficacy (reduction of pelvic pain) [ Time Frame: 12-18 months ] [ Designated as safety issue: No ]
Efficacy (reduction of pelvic pain)
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Endometriosis
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
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
Female
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Ukraine
 
NCT00225186
91234, 307059
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2014

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