Trial Information

Summary: Study to evaluate the safety and efficacy or oral doses of an investigational medication administered during menstruation for the treatment of menorrhagia

The objective of this study is to determine the efficacy and safety of a modified-release formulation of tranexamic acid to reduce menstrual blood loss in women with menorrhagia when administered during menstruation compared to placebo

Study Inclusion Criteria:

• Generally healthy women between 18 and 49 years of age with menorrhagia
• Normal pelvic exam and pap smear
• Written informed consent

Study Exclusion Criteria:

• History of significant hepatic or renal disease
• Abnormalities identified by the doctor on the screening physical
• History of bilateral oophorectomy or hysterectomy
• Women who are pregnant, breastfeeding or plan on becoming pregnant

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Trial listings updated: June 1, 2008 at 5:46:34 AM