Status:
COMPLETED
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole
Lead Sponsor:
Havah Therapeutics Pty Ltd
Conditions:
Mammographic Density
Eligibility:
FEMALE
35-55 years
Phase:
PHASE1
Brief 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 stra...
Eligibility Criteria
Inclusion
- Agree to and be capable of understanding and signing an Informed Consent Form.
- Patients seeking treatment with Investigational Product for the reduction in high mammographic breast density (MBD).
- 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.
- Volpara Density volumetric breast density of ≥15.5% (combined average both breasts)
- Age between 35-55 years inclusive.
- Body weight between 50-90 kg inclusive.
- BMI between 20-30 kg/m2 inclusive.
- Good venous access for venepuncture.
- In good general health without clinically significant cardiac, respiratory, or psychiatric disease.
- 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.
- 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.
Exclusion
- Presence of breast cancer.
- Previous or concomitant other malignancy (non-breast, other than skin) within the previous five years.
- Diabetes mellitus or glucose intolerance defined as a fasting glucose of ≥ 6 mmol/L.
- History of coronary artery disease.
- Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood.
- Existing testosterone, oestrogen and/or anastrozole treatment.
- Concomitant medication which induces or inhibits CYP3A4 (Listed in Appendix A).
- Current warfarin usage.
- Prolonged systemic corticosteroid treatment, inhalation and topical steroids allowed.
- Known hypersensitivity to any component of Investigational Product.
- Systemic reproductive hormone replacement therapy.
- Systemic hormonal contraception.
- 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.
- Use of any product containing ginseng within 30 days of screening.
- Pregnant or lactating women.
- Unable to comply with trial requirements.
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03314298
Start Date
August 14 2017
End Date
April 17 2018
Last Update
April 18 2018
Active Locations (1)
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1
Wellend Health
Toorak Gardens, South Australia, Australia, 5065