Safety and Efficacy of SH T00660AA in Treatment of Endometriosis

Endometriosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225186
• Other study ID #: 91234
• Secondary ID: 307059
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2005
• Last updated: January 8, 2014
• Start date: July 2004
• Est. completion date: March 2008

Study information

• Verified date: January 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate safety and efficacy of SH T00660AA for the treatment of endometriosis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• Visanne (SH T00660AA , BAY86-5258)
Daily long-term drug treatment (12 months), and post-treatment observation (6 months) in a subgroup of patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Germany,  Italy,  Ukraine, 

References & Publications (4)

Gerlinger C, Schumacher U, Faustmann T, Colligs A, Schmitz H, Seitz C. Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials. He — View Citation

Köhler G, Faustmann TA, Gerlinger C, Seitz C, Mueck AO. A dose-ranging study to determine the efficacy and safety of 1, 2, and 4mg of dienogest daily for endometriosis. Int J Gynaecol Obstet. 2010 Jan;108(1):21-5. doi: 10.1016/j.ijgo.2009.08.020. Epub . E — View Citation

Petraglia F, Hornung D, Seitz C, Faustmann T, Gerlinger C, Luisi S, Lazzeri L, Strowitzki T. Reduced pelvic pain in women with endometriosis: efficacy of long-term dienogest treatment. Arch Gynecol Obstet. 2012 Jan;285(1):167-73. doi: 10.1007/s00404-011-1 — View Citation

Strowitzki T, Faustmann T, Gerlinger C, Seitz C. Dienogest in the treatment of endometriosis-associated pelvic pain: a 12-week, randomized, double-blind, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2010 Aug;151(2):193-8. doi: 10.1016/j.ejo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment of the drug		12-18 months	Yes
Secondary	Efficacy (reduction of pelvic pain)		12-18 months	No

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