Published in Women's Health Weekly, March 31st, 2005
The trial was designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of two dose levels of NBI-56418 given once daily for 6 weeks in 60 healthy premenopausal women. The study demonstrated that NBI-56418 was safe and well tolerated. NBI-56418 demonstrated a dose-dependent suppression of estradiol that was observed throughout the duration of dosing.
The study was a double-blind, placebo-controlled trial involving...
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