A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 75 MG AND 150 MG DOSES OF ERB-041 ON THE REDUCTION OF SYMPTOMS ASSOCIATED WITH ENDOMETRIOSIS DURING TREATMEN...

Update Il y a 4 ans
Reference: EUCTR2006-000068-10

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 75 MG AND 150 MG DOSES OF ERB-041 ON THE REDUCTION OF SYMPTOMS ASSOCIATED WITH ENDOMETRIOSIS DURING TREATMENT AND POST TREATMENT IN REPRODUCTIVE-AGED WOMEN

Woman Man

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Extract

-To evaluate the superiority of ERB-041 relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive-aged women using the Biberoglu & Behrman (B&B) scale administered by the physician investigator. -To compare the safety profile of ERB-041 with placebo during 12 weeks of treatment.


Inclusion criteria

  • Reproductive-aged women with moderate to severe symptoms related to endometriosis. Subjects will have been diagnosed with endometriosis by laparoscopy or laparotomy within 10 years before visit 1B (screening)