A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
11
subcutaneous testosterone and anastrozole
Wellend Health
Toorak Gardens, South Australia, Australia
testosterone Cmax
Peak Plasma Concentration
Time frame: Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.
testosterone AUC
Area under the plasma concentration versus time curve
Time frame: Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.
testosterone T1/2
plasma half-life
Time frame: Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.
anastrozole Cmax
Peak Plasma Concentration
Time frame: Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.
anastrozole AUC
Area under the plasma concentration versus time curve
Time frame: Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.
anastrozole T1/2
plasma half-life
Time frame: Day 1, blood samples will be taken pre-dose and at 1, 2, 4, 8 and 12 hours and 9 am in the morning on Days 2, 3, 4, 5, 8, 15, 22, 29, 43, 57, 71 and 85.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
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To assess the safety and tolerability of T+Ai following a single dose of T+Ai by subcutaneous implantation. Biochemical and hematological will be evaluated and the number of participants with abnormal values or adverse events that are related to treatment will be recorded
Time frame: The outcome measures will be reported weekly until study completion-3 months
dihydrotestosterone metabolism
To description of the time course of dihydrotestosterone serum concentrations.
Time frame: 3 months
breast elasticity
Breast tissue elasticity will be measured by shear wave ultrasound at baseline and on Days 29, 57 and 85. A Supersonic Ultrasound will be carried out by four quadrant analysis of each breast with 6x3mm Q box analyses measured in kPa.
Time frame: Breast tissue elasticity will be measured by shear wave ultrasound at baseline and on Days 29, 57 and 85