Status:
COMPLETED
Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
Lead Sponsor:
Bayer
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the treatment of e...
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
- Pain associated with proven endometriosis, as determined by diagnostic measures within 24 months prior to start of treatment
- Women with cyclic menstrual bleeding- Good general health
- Willingness to use a barrier contraceptive method such as condoms but no hormonal contraception- Willingness to use only up to 3 Ibuprofen 400 tablets as pain killer for endometriosis-related pelvic pain - Age 18 to 45 years inclusive - Fertile and non-fertile
Exclusion
- Pregnancy, lactation- Bearing of an intra-uterine device
- Current use of hormonal agents.
- Actual or history of cardiovascular and further serious disorders
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00185341
Start Date
February 1 2005
End Date
February 1 2007
Last Update
May 2 2016
Active Locations (32)
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1
Hradec Králové, Czechia, 50036
2
Prague, Czechia, 12851
3
Prague, Czechia, 14700
4
Prague, Czechia, 15006