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 (Z)-Endoxifen amongst 24 volunteers; and
2) A three-arm placebo controlled study with our proprietary Oral (Z)-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.