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

Phase 2

Completed

• Conditions: Endometriosis
• Interventions: Drug: CCR1-Antagonist (BAY86-5047, ZK811752); Drug: Placebo

• Registration Number: NCT00185341
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCR-1 Receptor Antagonist	CCR1-Antagonist (BAY86-5047, ZK811752)	Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily
Placebo	Placebo	Subjects received placebo corresponding to verum

Primary Outcome Measures

Name	Time	Method
Individual absolute change in endometriosis associated pelvic pain (EAPP)	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
Individual change in intake of rescue medication	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	12 weeks