What: For the intermittent treatment of abnormal uterine bleeding associated with Leiomyomas.
Who: Post-menopausal females 18-50 (inclusive)
Inclusion (if you fall into this category you may qualify): Have experienced abnormal uterine bleeding (heavy or prolonged).
If of childbearing potential, must be practicing, from the start of the screening period through study completion, a non-hormonal method(s) of contraception.
If not of childbearing potential, must have had bilateral tubal ligation sterilization at least 6 months before the screening visit.
Exclusion (if you fall into this category you may not qualify): Has a history of uterine surgery that would interfere with the study.
Has a known coagulation disorder including bleeding disorder.
Has a history of, or current uterine, cervix ovarian, or breast cancer.
Has a Pap smear suggestive of a high-grade precancerous lesion(s).
Has an intrauterine device (IUD) as a method of birth control.
Has symptoms or signs of pelvic infection.
Has a diagnosis of Polycystic Ovary Syndrome.
Has intolerance to endometrial biopsies.
Has known endometrial polyp(s) > 2cm.
Has undergone treatment with a gonadotropin releasing hormone agonist within 5 months prior to the initial screening.
Has any concomitant or active disease or condition.
Has a positive pregnancy test at screening or at anytime during the course of the study, or is nursing or planning a pregnancy at any time during participation in the study.
Duration: 36 weeks