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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03314298




Registration number
NCT03314298
Ethics application status
Date submitted
6/08/2017
Date registered
19/10/2017
Date last updated
18/04/2018

Titles & IDs
Public title
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole
Scientific title
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women
Secondary ID [1] 0 0
HAV-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mammographic Density 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - testosterone anastrozole

Experimental: testosterone anastrozole implant - testosterone 80mg Anastrozole 4 mg single as a subcutaneous pellet


Treatment: Drugs: testosterone anastrozole
subcutaneous testosterone and anastrozole

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
testosterone Cmax - Peak Plasma Concentration
Timepoint [1] 0 0
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.
Primary outcome [2] 0 0
testosterone AUC - Area under the plasma concentration versus time curve
Timepoint [2] 0 0
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.
Primary outcome [3] 0 0
testosterone T1/2 - plasma half-life
Timepoint [3] 0 0
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.
Primary outcome [4] 0 0
anastrozole Cmax - Peak Plasma Concentration
Timepoint [4] 0 0
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.
Primary outcome [5] 0 0
anastrozole AUC - Area under the plasma concentration versus time curve
Timepoint [5] 0 0
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.
Primary outcome [6] 0 0
anastrozole T1/2 - plasma half-life
Timepoint [6] 0 0
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.
Secondary outcome [1] 0 0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] - 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
Timepoint [1] 0 0
The outcome measures will be reported weekly until study completion-3 months
Secondary outcome [2] 0 0
dihydrotestosterone metabolism - To description of the time course of dihydrotestosterone serum concentrations.
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Breast tissue elasticity will be measured by shear wave ultrasound at baseline and on Days 29, 57 and 85

Eligibility
Key inclusion criteria
1. Agree to and be capable of understanding and signing an Informed Consent Form.

2. Patients seeking treatment with Investigational Product for the reduction in high
mammographic breast density (MBD).

3. Pre-menopausal levels of Follicular stimulating hormone/Leutinizing
hormone/estradiol(follicle stimulating hormone/luteinizing hormone/oestrogen)
according to the definition of "pre-menopausal range" for the laboratory involved.

4. Volpara Density volumetric breast density of =15.5% (combined average both breasts)

5. Age between 35-55 years inclusive.

6. Body weight between 50-90 kg inclusive.

7. BMI between 20-30 kg/m2 inclusive.

8. Good venous access for venepuncture.

9. In good general health without clinically significant cardiac, respiratory, or
psychiatric disease.

10. Negative pregnancy test in women of childbearing potential (premenopausal or less than
12 months of amenorrhea post-menopause, and who have not undergone surgical
sterilisation), no more than seven days before the first dose of Investigational
Product.

11. For women of childbearing potential who are sexually active, agreement to use a highly
effective, non-hormonal form of contraception (Mirena (TM) allowed) during and for at
least six months after completion of treatment with Investigational Product; OR, a
fertile male partner willing and able to use effective non-hormonal means of
contraception (barrier method of contraception in conjunction with spermicidal jelly,
or surgical sterilisation) during and for at least six months after completed dosing
Investigational Product.
Minimum age
35 Years
Maximum age
55 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence of breast cancer.

2. Previous or concomitant other malignancy (non-breast, other than skin) within the
previous five years.

3. Diabetes mellitus or glucose intolerance defined as a fasting glucose of = 6 mmol/L.

4. History of coronary artery disease.

5. Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected
blood.

6. Existing testosterone, oestrogen and/or anastrozole treatment.

7. Concomitant medication which induces or inhibits CYP3A4 (Listed in Appendix A).

8. Current warfarin usage.

9. Prolonged systemic corticosteroid treatment, inhalation and topical steroids allowed.

10. Known hypersensitivity to any component of Investigational Product.

11. Systemic reproductive hormone replacement therapy.

12. Systemic hormonal contraception.

13. Participation in another clinical trial of an Investigational Product within 30 days
of entry into the present trial or within 4-5 half-lives of the Investigational
Product, whichever is the longer.

14. Use of any product containing ginseng within 30 days of screening.

15. Pregnant or lactating women.

16. Unable to comply with trial requirements.

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Wellend Health - Toorak Gardens
Recruitment postcode(s) [1] 0 0
5065 - Toorak Gardens

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Havah Therapeutics Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from
subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women
Trial website
https://clinicaltrials.gov/show/NCT03314298
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen N Birrell, Md PhD
Address 0 0
Wellend Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications