A Phase II, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Assess the Efficacy and Safety of NBI-56418 in Subjects with Endometriosis

eurocrine Biosciences, INC0 sites180 target enrollmentMarch 17, 2008

Overview

No summary available.

Registry

who.int

Start Date

March 17, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

eurocrine Biosciences, INC

•To participate in this study, subjects must:
•Be female, aged 18 to 45 years, inclusive.
•Have a total Composite Pelvic Signs and Symptoms Score (CPSSS)
•of \=6 at screening.
•Have a score of at least 2 for the dysmenorrhea CPSSS component and at least 1
•for the nonmenstrual pelvic pain CPSSS component at baseline (Day 1, Week 1\).
•Be at 2 to 5 days (inclusive) after the onset of menses prior to randomization
•Have had a diagnosis of endometriosis made following laparoscopic visualization of
•the disease within 5 years of the start of screening with recurrent or persistent
•Have documented negative mammogram results within 12 months of screening if

•Subjects will be excluded from the study if they:
•Were administered a GnRH agonist, GnRH antagonist, danazol, or have received
•any of these agents within 6 months of the start of screening.
•Were administered subcutaneous medroxyprogesterone acetate (DMPA\-SC) or i.m.
•medroxyprogesterone acetate (DMPA\-IM), or have received either of these agents
•within 3 months of the start of screening.
•Have been nonresponsive to GnRH agonist or antagonist therapy for the
•management of endometriosis.
•Are currently using hormonal contraception (for endometriosis or contraception) or
•other forms of hormonal therapy for endometriosis or have received such therapy