Clinical trial NCT00225186: Safety and Efficacy of SH T00660AA in Treatment of Endometriosis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-23
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety assessment of the drug
timeFrame: 12-18 months
Secondary outcomes:
measure: Efficacy (reduction of pelvic pain)
timeFrame: 12-18 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Tuebingen
country: Germany
state: Baden-Württemberg
city: Krumbach
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Nuernberg
country: Germany
state: Bayern
city: Giessen
country: Germany
state: Hessen
city: Mühlheim
country: Germany
state: Hessen
city: Aachen
country: Germany
state: Nordrhein-Westfalen
city: Gevelsberg
country: Germany
state: Nordrhein-Westfalen
city: Münster
country: Germany
state: Nordrhein-Westfalen
city: Kalbe
country: Germany
state: Sachsen-Anhalt
city: Dippoldiswalde
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Marienberg
country: Germany
state: Sachsen
city: Weißig
country: Germany
state: Sachsen
city: Lübeck
country: Germany
state: Schleswig-Holstein
city: Greifswald
country: Germany
city: Brescia
country: Italy
city: Cagliari
country: Italy
city: Napoli
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Chernivtsi
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Kiev
country: Ukraine
city: Vinnitsa
country: Ukraine
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.ejogrb.2010.04.002. Epub 2010 May 5.
citation: 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.
citation: 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.
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/s00404-011-1941-7. Epub 2011 Jun 17.