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

Bayer

Status and phase

Completed

Phase 2

Conditions

Endometriosis

Treatments

Drug: Placebo

Drug: CCR1-Antagonist (BAY86-5047, ZK811752)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00185341

2004-000630-37 (EudraCT Number)

91399

308601

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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