NCT03314298

A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole

A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Havah Therapeutics Pty Ltd · Industry
• Sex: Female
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Mammographic Density

Interventions

Type	Name	Description
DRUG	testosterone anastrozole	subcutaneous testosterone and anastrozole

Timeline

• Start date: 2017-08-14
• Primary completion: 2018-04-17
• Completion: 2018-04-17
• First posted: 2017-10-19
• Last updated: 2018-04-18

Locations

1 site across 1 country: Australia