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Clinical Trial Summary

A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women


Clinical Trial Description

The trial is of open label single centre design. The serum concentrations of testosterone and plasma concentrations of anastrozole will be measured in 12 premenopausal women. Participants will be stratified in a 50:50 manner in two BMI (Body Mass Index) groups, <25 and 25 kg/m2, respectively. There will be a lead group of two participants in whom the serum/plasma concentrations will be examined after the first four weeks, to determine whether the sampling schedule adequately describes the serum/plasma concentration-time profiles or should be adjusted. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03314298
Study type Interventional
Source Havah Therapeutics Pty Ltd
Contact
Status Completed
Phase Phase 1
Start date August 14, 2017
Completion date April 17, 2018

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