Clinical Trials Resource Center

Menstrual Disorders

May 16, 2005

Ascend Therapeutics presented positive results of a phase II trial of a topical gel formulation of 4- hydroxytamoxifen (4-OHT), for the treatment of menstrual-cycle related mastalgia, at the 53rd Annual Clinical Meeting of the American College of Obstetricians and Gynecologists. Data from the study indicated that the highest dose of the drug significantly reduced symptoms severity vs. placebo, as measured by primary Visual Analogue Scale score (-32.1 mm vs. -19.3 mm, respectively; p=0.034), and secondary physician global assessments of pain (OR, 0.32; p=0.01), tenderness (OR, 0.33; p=0.012), and nodularity (OR, 0.30; p=0.017), and patient assessment of pain (OR, 0.36; p=0.022). No disruptions of menstrual cycles or menses were noted over the course of treatment, and plasma hormone levels were unaffected. This randomized, double- blind, placebo-controlled, dose-ranging study enrolled 130 adult premenopausal women with a history of cyclic mastalgia, who received one of two doses of 4-OHT (2 mg once or twice daily) for 4 menstrual cycles.

October 13, 2003

GlaxoSmithKline reported positive results from a post-marketing study investigating Imitrex (sumatriptan succinate) for the treatment of menstrual migraines. Results showed that more than half of the subjects treated with Imitrex (61% and 51% at 100 mg & 50 mg respectively) experienced more complete relief of migraine pain two hours after treatment than with placebo (29%). Data also showed that 51% and 47% of subjects, at 100 mg and 50 mg were free of migraine pain and associated symptoms such as nausea, vomiting, and sensitivity to light and sound versus 25% with placebo. The randomized, double-blind, placebo-controlled study enrolled 349 female subjects with at least a one-year history of migraine and a six-month history of regularly occurring menstrually associated migraines. Subjects were randomized to receive Imitrex 50 mg, 100 mg, or placebo. Pain was rated by subjects on a standard four-point scale. Results were reported in the October issue of Obstetrics & Gynecology.<

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