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Janet A Chollet

Fred H Mermelstein

Bernadette Klamerus

The present invention provides novel pharmaceutical compositions containing triphenylethylene derivative compounds, and methods of using the composition for treatment of symptoms associated with atrophic vaginitis. The pharmaceutical compositions are prepared for the vaginal administration of triphenylethylene derivative compounds in single or combination therapies. Preferably, the triphenylethylene derivative is tamoxifen.

Method of treating atrophic vaginitis

The present invention provides topical compositions and methods for administering tamoxifen citrate while minimizing the incidence and or severity of adverse drug experiences associated with tamoxifen therapy. In one aspect, these compositions and methods provide a lower plasma concentration of tamoxifen metabolites, such as 4-hydroxytamoxifen and N-desmethyltamoxifen, which is presumed to be contributing at least in part to some of the adverse drug experiences, while maintaining sufficient tamoxifen as the sole active agent to benefit a subject with tamoxifen therapy.

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Newton Center, MA, United States of America

Janet A Chollet