Trial Information

Summary: Randomized, double-blind, placebo controlled multicenter study to evaluate efficacy and safety 0.65 g and 1.3 g oral doses of study drug administered during menstruation for the treatment of menorrhagia.

The primary objective of this study is an assessment of the study drug to reduce menstrual blood loss in women with menorrhagia when administered during menstruation.

Several Study Inclusion Criteria Include:

• Generally healthy women 18-49 years of age with cyclic heavy menstrual bleeding associated with menorrhagia. Subjects must report a history of 3 or more consecutive days of heavy bleeding in at least 4 of the last 6 menstrual periods.
• Regularly occurring menstrual periods of =10 days with 21-35 days from the start of one period to the start of the next menstrual period for at least the last 6 months.

Several Study Exclusion Criteria Include:

• History or presence of clinically significant hepatic or renal disease or other medical disease that might confound the study or be detrimental to the subject.
• History or presence of endometrial polyps, endometrial hyperplasia, endometrial carcinoma or cervical carcinoma.

For more information,

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