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www.fdanews.com/articles/91870-meditrina-studying-aromatase-inhibitor-for-treating-abnormal-uterine-bleeding

Meditrina Studying Aromatase Inhibitor for Treating Abnormal Uterine Bleeding

April 10, 2007

Meditrina Pharmaceuticals has announced the start of a Phase II clinical trial for its lead product candidate, Femathina.

Femathina is an aromatase inhibitor that Meditrina is repurposing for the treatment of several serious women's health conditions including endometrial thinning prior to endometrial ablations in premenopausal women with abnormal uterine bleeding.

Meditrina is currently enrolling women in a U.S.-based, multicenter, placebo-controlled study that will evaluate the appropriate time during the menstrual cycle in which to initiate dosing in premenopausal women to either induce or maintain a thin endometrium. The issue of timing during the menstrual cycle is crucial in order to progress into a subsequent Phase II dose-ranging trial, as well as a larger pivotal Phase III trial, which is scheduled to commence in early 2008.

Abnormal uterine bleeding can be caused by: changes in hormonal balance; pregnancy; miscarriage; ectopic pregnancy; problems linked to some birth control methods, such as intrauterine devices or birth control pills; infection of the uterus or cervix; fibroids; problems with blood clotting; polyps; certain types of cancers, such as cancer of the uterus, cervix or vagina; and chronic medical conditions such as diabetes.

Femathina is an aromatase inhibitor. Aromatase inhibitors reduce the amount of estrogen circulating in the body by binding to and inhibiting the enzyme aromatase, which is responsible for converting certain hormones to estrogen.