A phase I, placebo controlled, dose escalation safety and pharmacokinetic study of (Z)-Endoxifen in healthy female volunteers.

This double-blinded study consisted of two parts:
1) A three-arm placebo controlled study with our proprietary formula of Topical Endoxifen amongst 24 volunteers; and
2) A three-arm placebo controlled study with our proprietary Oral Endoxifen amongst 24 volunteers, in both single and multiple dose administrations. One woman in the Topical Part (receiving placebo) was dropped due to lack of compliance and replaced.