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

Study Overview

• Status: Completed
• Conditions: Endometriosis
• Intervention / Treatment: Drug: Visanne (SH T00660AA , BAY86-5258)

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Greifswald, Germany, 17487
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69115
    • Tuebingen, Baden-Württemberg, Germany, 72076
  • Bayern
    • Krumbach, Bayern, Germany, 86381
    • München, Bayern, Germany, 81241
    • Nuernberg, Bayern, Germany, 90419
  • Hessen
    • Giessen, Hessen, Germany, 35392
    • Mühlheim, Hessen, Germany, 63165
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
    • Gevelsberg, Nordrhein-Westfalen, Germany, 58285
    • Münster, Nordrhein-Westfalen, Germany, 48129
  • Sachsen
    • Dippoldiswalde, Sachsen, Germany, 01744
    • Leipzig, Sachsen, Germany, 04103
    • Marienberg, Sachsen, Germany, 09496
    • Weißig, Sachsen, Germany, 01474
  • Sachsen-Anhalt
    • Kalbe, Sachsen-Anhalt, Germany, 39624
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
• 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, 01030
  • Kiev, Ukraine, 04107
  • Kiev, Ukraine, 04210
  • Vinnitsa, Ukraine, 21000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety assessment of the drug	12-18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Efficacy (reduction of pelvic pain)	12-18 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.ejogrb.2010.04.002. Epub 2010 May 5.
• Kohler 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. Erratum In: Int J Gynaecol Obstet. 2011 Mar;112(3):257.
• 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. Health Qual Life Outcomes. 2010 Nov 24;8:138. doi: 10.1186/1477-7525-8-138.
• 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/s00404-011-1941-7. Epub 2011 Jun 17.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: September 22, 2005
• First Submitted That Met QC Criteria: September 22, 2005
• First Posted (Estimate): September 23, 2005

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 91234; 307059 (Other Identifier: company internal)