This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
6
Novartis Investigative Site
Anaheim, California, United States
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
Time frame: 8 months
Pharmacokinetic Profille of BGS649 as Described by AUC0-672h
AUC0-672 is a measurement of how much drug reaches a person's bloodstream in a given period of time after a dose is given. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Time frame: 8 hours
Pharmacokinetic Profile of BGS649 as Described by Cmax
The peak plasma concentration of BGS649 after dosing at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occured at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Time frame: 8 hours
Pharmacokinetic Profile of BGS649 as Described by Tmax
Time taken to reach the maximum concentration in plasma of BGS649 at cycle 2 and cycle 4. Measurements were performed at dose 1 (in cycle 2) and after dose 2 (in cycle 4). Sampling occurred at pre-dose, 0.5-1.5h and 4-8 h post-dose.
Time frame: 8 hours
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