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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: September 12, 2005   Last Updated: 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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Arm 1: Experimental Drug: CCR1-Antagonist (BAY86-5047, ZK811752, SH T 04268H)
Given orally in a dose of 600 mg three times daily over 12 weeks
Arm 2: Placebo Comparator 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

  Show 37 Study Locations
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
Click here to find results for studies related to marketed products  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers: 91399, EudraCT No. 2004-000630-37, 308601
Study First Received: September 12, 2005
Last Updated: July 14, 2009
ClinicalTrials.gov Identifier: NCT00185341     History of Changes
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:
Genital Diseases, Female
Endometriosis

ClinicalTrials.gov processed this record on February 08, 2010



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