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Therapeutic Areas: Obstetrics/Gynecology
Disease Category: Menstrual Disorders
Trial Information
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
Holy Cross Hospital Research Center
4875 N. Federal Hwy, Suite 700
Fort Lauderdale, FL 33308
Phone: 954-229-8400
Fax: 954-229-8597
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