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Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185341
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : May 2, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Endometriosis Drug: CCR1-Antagonist (BAY86-5047, ZK811752) Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : February 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CCR-1 Receptor Antagonist
Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Drug: CCR1-Antagonist (BAY86-5047, ZK811752)
Given orally in a dose of 600 mg three times daily over 12 weeks

Placebo Comparator: Placebo
Subjects received placebo corresponding to verum
Drug: Placebo

Primary Outcome Measures :
  1. Individual absolute change in endometriosis associated pelvic pain (EAPP) [ Time Frame: 12 weeks ]
    EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication

  2. Individual change in intake of rescue medication [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185341

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Czech Republic
Hradec Kralove, Czech Republic, 50036
Praha, Czech Republic, 12851
Praha, Czech Republic, 14700
Praha, Czech Republic, 15006
Aarhus, Denmark, 8200
Glostrup, Denmark, 2600
Helsinki, Finland, 00029
Helsinki, Finland, 00100
Joensuu, Finland, 80210
Kuopio, Finland, 70110
Oulu, Finland, 90100
Turku, Finland, 20100
Bordeaux, France, 33000
Clermont Ferrand, France, 63000
Lyon, France, 69003
Amsterdam, Netherlands, 1061 AE
Amsterdam, Netherlands, 1081 HV
Maastricht, Netherlands, 6229 HX
Nijmegen, Netherlands, 6525 GA
Oviedo, Asturias, Spain, 33006
Barcelona, Spain, 08022
Barcelona, Spain, 08036
Madrid, Spain, 28040
Madrid, Spain, 28046
Sevilla, Spain, 41014
Valencia, Spain, 46010
Göteborg, Sweden, 41685
Lund, Sweden, 22185
Skövde, Sweden, 541 85
Stockholm, Sweden, 141 86
Stockholm, Sweden, 182 88
Uppsala, Sweden, 75185
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer Identifier: NCT00185341    
Other Study ID Numbers: 91399
2004-000630-37 ( EudraCT Number )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: May 2, 2016
Last Verified: April 2016
Keywords provided by Bayer:
Endometriosis associated pelvic pain
Additional relevant MeSH terms:
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Pelvic Pain
Genital Diseases, Female
Neurologic Manifestations
Signs and Symptoms