Trial Condition(s):

Endometriosis

Study to investigate the efficacy of a non-hormonal drug against endometriosis associated pelvic pain

Bayer Identifier:

91399

ClinicalTrials.gov Identifier:

NCT00185341

EudraCT Number:

2004-000630-37

Study Completed

Trial Purpose

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 endometriosis associated pelvic pain (EAPP) in comparison to placebo.

Inclusion Criteria
- 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 Criteria
- Pregnancy, lactation- Bearing of an intra-uterine device
 - Current use of hormonal agents. 
 - Actual or history of cardiovascular and further serious disorders

Trial Summary

Enrollment Goal
110
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
CCR-1 Receptor Antagonist (BAY86-5047)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kuopio, Finland, 70110

Status
Terminated
 
Locations

Investigative Site

Amsterdam, Netherlands, 1081 HV

Status
Completed
 
Locations

Investigative Site

Maastricht, Netherlands, 6229 HX

Status
Terminated
 
Locations

Investigative Site

Nijmegen, Netherlands, 6500 HB

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 141 86

Status
Completed
 
Locations

Investigative Site

Göteborg, Sweden, 41685

Status
Completed
 
Locations

Investigative Site

Skövde, Sweden, 54185

Status
Completed
 
Locations

Investigative Site

Oviedo, Spain, 33006

Status
Completed
 
Locations

Investigative Site

Valencia, Spain, 46010

Status
Completed
 
Locations

Investigative Site

Sevilla, Spain, 41014

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28016

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90100

Status
Completed
 
Locations

Investigative Site

Turku, Finland, 20100

Status
Completed
 
Locations

Investigative Site

Praha, Czech Republic, 15006

Status
Completed
 
Locations

Investigative Site

Praha, Czech Republic, 14700

Status
Completed
 
Locations

Investigative Site

Aarhus, Denmark, 8200

Status
Completed
 
Locations

Investigative Site

Oulu, Finland, 90100

Status
Terminated
 
Locations

Investigative Site

Joensuu, Finland, 80210

Status
Terminated
 
Locations

Investigative Site

Turku, Finland, 20100

Status
Terminated
 
Locations

Investigative Site

Helsinki, Finland, 00029

Status
Terminated
 
Locations

Investigative Site

Amsterdam, Netherlands

Status
Completed
 
Locations

Investigative Site

Stockholm, Sweden, 182 88

Status
Completed
 
Locations

Investigative Site

Uppsala, Sweden, 751 85

Status
Completed
 
Locations

Investigative Site

Lund, Sweden, 221 85

Status
Completed
 
Locations

Investigative Site

Madrid, Spain, 28040

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08036

Status
Completed
 
Locations

Investigative Site

Barcelona, Spain, 08022

Status
Terminated
 
Locations

Investigative Site

Joensuu, Finland, 80210

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00029

Status
Completed
 
Locations

Investigative Site

Kuopio, Finland, 70110

Status
Completed
 
Locations

Investigative Site

Helsinki, Finland, 00180

Status
Completed
 
Locations

Investigative Site

Praha, Czech Republic, 12851

Status
Completed
 
Locations

Investigative Site

Clermont Ferrand, France, 63000

Status
Terminated
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 02

Status
Completed
 
Locations

Investigative Site

Glostrup, Denmark, 2600

Status
Completed
 
Locations

Investigative Site

Bordeaux, France, 33000

Status
Completed
 
Locations

Investigative Site

Lyon, France, 69003

Status
Terminated
 

Trial Design