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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00185341

Enrollment

110

Registered

2005-09-16

Start date

2005-02-28

Completion date

2007-02-28

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Endometriosis associated pelvic pain

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.

Interventions

DRUGCCR1-Antagonist (BAY86-5047, ZK811752)

Given orally in a dose of 600 mg three times daily over 12 weeks

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Number of participants with adverse events	12 weeks

Countries

Czechia, Denmark, Finland, France, Netherlands, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026