Clinical trial NCT00185341: Study to Investigate the Efficacy of a Non-hormonal Drug Against Endometriosis Associated Pelvic Pain
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Keywords: Endometriosis associated pelvic pain
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Individual absolute change in endometriosis associated pelvic pain (EAPP)
timeFrame: 12 weeks
measure: Individual change in intake of rescue medication
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hradec Kralove
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Praha
country: Czech Republic
city: Aarhus
country: Denmark
city: Glostrup
country: Denmark
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Joensuu
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Turku
country: Finland
city: Bordeaux
country: France
city: Clermont Ferrand
country: France
city: Lyon
country: France
city: Amsterdam
country: Netherlands
city: Amsterdam
country: Netherlands
city: Maastricht
country: Netherlands
city: Nijmegen
country: Netherlands
city: Oviedo
country: Spain
state: Asturias
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Lund
country: Sweden
city: Skövde
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: