Study to Investigate the Efficacy of a Non-Hormonal Drug Against Endometriosis Associated Pelvic Pain - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185341

Purpose

The purpose of this study is to investigate if SH T 04268H is effective in the treatment of endometriosis associated pelvic pain.

Condition	Intervention	Phase
Endometriosis	Drug: SH T 04268H	Phase II

MedlinePlus related topics: Endometriosis Pelvic Pain

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability and Efficacy of a Chemokine Receptor Antagonist Given Orally for the Treatment of Endometriosis

Further study details as provided by Bayer:

Primary Outcome Measures:

"Individual change in endometriosis associated pelvic pain (EAPP) from Baseline to end of treatment (EOT)" and "individual change in intake of rescue medication from Baseline to EOT".

Secondary Outcome Measures:

Study Start Date:	February 2005
Study Completion Date:	February 2007

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185341

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

+490 30 468 11800

More Information

Study ID Numbers:	308601, EudraCT No. 2004-000630-37
Study First Received:	September 12, 2005
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00185341
Health Authority:	Finland: National Agency for Medicines; Sweden: Medical Products Agency; Spain: Ministry of Health and Consumption; Denmark: Laegemiddelsstryrelsen; Czech Republic: State Institute for Drug Control

Keywords provided by Bayer:

Endometriosis associated pelvic pain

Study placed in the following topic categories:

Genital Diseases, Female
Pelvic Pain
Endometriosis
Pain

ClinicalTrials.gov processed this record on January 14, 2009