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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


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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