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NBI-56418

Phase 2

Endometriosis | Small molecule | Endocrine |Abbott Laboratories|Last Updated: Feb 22, 2012

Target and mechanism

ModalitySmall molecule

Also known as NBI-56418 (GnRH antagonist)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76

FDA Designations

No designations recorded

Clinical trial landscape

NBI-56418 · 1 trial · 1 indication

Phase 2 1
NCT00109512Endometriosis Trial: Study of NBI-56418 in EndometriosisEndometriosis
COMPLETED76 Analytics
PHASE2COMPLETED
Endometriosis Trial: Study of NBI-56418 in Endometriosis
Endometriosis
NCT0010951276
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Study Endpoints

Primary Endpoints

Total Composite Pelvic Signs and Symptom Scale (CPSSS) scores
Every 4 weeks

This scale is used to assess the signs (pelvic tenderness and induration) and symptoms (nonmenstrual pelvic pain, dysmenorrhea and dyspareunia) associated with endometriosis.

Secondary Endpoints

Endometriosis Health Profile-5 (EHP-5)
Every 4 weeks
Visual Analog Scale (VAS) scores
Every 4 weeks
Number of Subjects with Adverse Events
Up to 24 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placeboPLACEBO_COMPARATOR -
NBI-56418 75 mgEXPERIMENTAL -
NBI-56418 150 mgEXPERIMENTAL -

Interventions

NameTypeDescription
NBI-56418 (GnRH antagonist)DRUG -
placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 49 Years
SexFEMALE
Healthy VolunteersNo
Study Sites15

Inclusion Criteria * Be female, aged 18 to 49 years, inclusive. * Have pelvic pain and dysmenorrhea resulting in a Composite Pelvic Sign and Symptoms Score (CPSSS) of ≥ 6. * Have had a diagnosis of endometriosis made following laparoscopic visualization of the disease within the last 5 years of the...

Countries:United States
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