2.1. Study Design
fibroids
FIBROIDS
This was a pharmacokinetic and safety study designed to assess the possible effects of a green tea extract (GTE) alone versus a GTE with a medication used for ovarian stimulation (clomiphene citrate or letrozole) given to women with or without fibroids under IND (#150951) from the US Food and Drug Administration. Green tea extract capsules were supplied by Beehive Botanicals Inc. (Hayward, Wisconsin), and each capsule contained on average, 400 mg of GTE with 45% EGCG. Subjects were instructed to take 4 capsules with food at breakfast daily, which is equivalent to a daily EGCG dose of 720 mg. GTE capsules were initiated after verifying screening eligibility and prior to the subject’s next cycle and were continued until the end of the study, which is around 30–35 days after the onset of their next menstrual cycle. An ovarian stimulation medication was started between cycle days 2–5 for subjects randomized to either regimen (clomiphene citrate or letrozole, treatment arms II and III, respectively), being 100 mg clomiphene citrate or 2.5 mg of letrozole for 5 days. A total of five visits were conducted throughout this study, including the screening visit followed by four study visits; liver function tests were monitored at every visit except at the mid-cycle ultrasound visit (