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Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
This study has been completed.

First Received on September 12, 2005.   Last Updated on July 14, 2009   History of Changes
Sponsor: Bayer
Information provided by: Bayer
ClinicalTrials.gov Identifier: NCT00185341
  Purpose

The purpose of this study is to investigate if SH T 04268H is effective in the treatment of endometriosis associated pelvic pain.


Condition Intervention Phase
Endometriosis
 Drug: CCR1-Antagonist (BAY86-5047, ZK811752, SH T 04268H)
Drug: Placebo
 Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability and Efficacy of the CCR1 Antagonist ZK 811752, Given Orally in a Dose of 600 mg Three Times Daily, for the Treatment of Endometriosis Over 12 Weeks

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis Pelvic Pain
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Individual change in endometriosis associated pelvic pain (EAPP) [ Time Frame: From Baseline to End Of Treatment (EOT) ]
  • Individual change in intake of rescue medication [ Time Frame: From Baseline to EOT ]

Secondary Outcome Measures:
  • Adverse Event Collection [ Time Frame: Throughout the whole study ]

Enrollment: 110
Study Start Date: February 2005
Study Completion Date: February 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: CCR1-Antagonist (BAY86-5047, ZK811752, SH T 04268H)
Given orally in a dose of 600 mg three times daily over 12 weeks
Placebo Comparator: Arm 2 Drug: Placebo
Placebo

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Pregnancy, lactation
  • Bearing of an intra-uterine device
  • Current use of hormonal agents.
  • Actual or history of cardiovascular and further serious disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00185341

Locations
Czech Republic
Hradec Kralove, Czech Republic, 50036
Praha, Czech Republic, 15006
Praha, Czech Republic, 12851
Praha, Czech Republic, 14700
Denmark
Aarhus, Denmark, 8200
Glostrup, Denmark, 2600
Finland
Helsinki, Finland, 00100
Helsinki, Finland, 00029
Joensuu, Finland, 80210
Kuopio, Finland, 70110
Oulu, Finland, 90100
Turku, Finland, 20100
France
Bordeaux, France, 33000
Clermont Ferrand, France, 63000
Lyon, France, 69003
Netherlands
Amsterdam, Netherlands, 1061 AE
Amsterdam, Netherlands, 1081 HV
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6525 GA
Spain
Oviedo, Asturias, Spain, 33006
Barcelona, Spain, 08036
Barcelona, Spain, 08022
Madrid, Spain, 28040
Madrid, Spain, 28046
Sevilla, Spain, 41014
Valencia, Spain, 46010
Sweden
Göteborg, Sweden, 41685
Lund, Sweden, 22185
Skövde, Sweden, 541 85
Stockholm, Sweden, 182 88
Stockholm, Sweden, 141 86
Uppsala, Sweden, 75185
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00185341     History of Changes
Other Study ID Numbers: 91399, EudraCT No. 2004-000630-37, 308601
Study First Received: September 12, 2005
Last Updated: July 14, 2009
Health Authority: Finland: Finnish Medicines Agency;   Sweden: Medical Products Agency;   Spain: Ministry of Health and Consumption;   Denmark: Danish Medicines Agency;   Czech Republic: State Institute for Drug Control

Keywords provided by Bayer:
Endometriosis associated pelvic pain

Additional relevant MeSH terms:
Endometriosis
Pelvic Pain
Genital Diseases, Female
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012



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