Northern California Research is conducting a study for uterine fibroids with heavy menstrual bleeding. Uterine fibroids (myoma) are harmless (benign), hormone-sensitive, smooth muscle tumors of the uterus. They are the most common tumor of the female reproductive tract in premenopausal women and are usually not noticeable. Uterine fibroids affect approximately 4 out of 10 women between the ages of 35 and 55. Fibroids can cause heavy menstrual bleeding, abdominal pressure, abdominal pain, increased urinary frequency, and infertility. Today, uterine fibroids are usually treated by surgery; however, depending on the extent of the surgery, this may cause infertility.
We are seeking FDA approval for a new medication to asses if it is safe and can reduce heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The study sponsor will provide all necessary sanitary items. You will be required to collect your used sanitary products and return to the site within the specific time period. The study is double-blind, meaning that neither you nor your study doctor/staff will know which study drug you will receive. You will be randomized into one out of 5 different study medication groups: you have an equal chance of being in any of the 5 study groups. There’s a 20% chance that you will only receive placebo. "Add-back" is a FDA approved medication, E2-Neta, provided to help with possibly bone density loss.
· Placebo study medication plus placebo add-back (100 subjects)
· 100 mg study medication plus placebo add-back (100 subjects)
· 100 mg study medication plus add-back (low dose) (100 subjects)
· 200 mg study medication9 plus placebo add-back (100 subjects)
· 200 mg study medication plus add-back (standard dose)