Mammographic DensityPhase 1NCT03314298
A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole
A Phase 1 study testing testosterone anastrozole in people with Mammographic Density, run by Havah Therapeutics Pty Ltd at 1 site in Australia.
Trial summary
A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammographic Density
- What is being tested?
- testosterone anastrozole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Aug 2017to 17 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women
A single dose trial to evaluate the pharmacokinetics of testosterone and anastrozole from subcutaneous testosterone and anastrozole (T+Ai) in premenopausal women
Read the 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
- Being tested
- testosterone anastrozole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
testosterone anastrozoleDrug
Also called testosterone, anastrozole
subcutaneous testosterone and anastrozole
| Study group | Role | What they receive |
|---|---|---|
| testosterone anastrozole implant | Experimental | testosterone 80mg Anastrozole 4 mg single as a subcutaneous pellet Receives: Drug: testosterone anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
testosterone Cmax
Peak Plasma Concentration
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 outcomes (3)
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
Measured: The outcome measures will be reported weekly until study completion-3 months
dihydrotestosterone metabolism
To description of the time course of dihydrotestosterone serum concentrations.
Measured: 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.
Measured: Breast tissue elasticity will be measured by shear wave ultrasound at baseline and on Days 29, 57 and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start14 Aug 2017
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammographic DensityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open labelled pharmacokinetic study
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Havah Therapeutics Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen N Birrell, Md PhD, Principal investigator, Wellend Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314298
- Sponsor's protocol ID
- HAV-001
- Status last verified
- Oct 2017
- First submitted
- 6 Aug 2017
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Trial to Evaluate the Pharmacokinetics of Testosterone and Anastrozole From Subcutaneous Testosterone and Anastrozole (T+Ai) in Premenopausal Women
- ClinicalTrials.gov ID
- NCT03314298
- Acronym / sponsor ID
- HAV-001
- Conditions
- Mammographic Density
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Havah Therapeutics Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 19 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open labelled pharmacokinetic study
| Arm | Type | Receives |
|---|---|---|
| testosterone anastrozole implant | Experimental | Drug: testosterone anastrozoletestosterone 80mg Anastrozole 4 mg single as a subcutaneous pellet |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| testosterone anastrozoleAlso: testosterone, anastrozolesubcutaneous testosterone and anastrozole | Drug | testosterone anastrozole implant |
Primary outcome
testosterone Cmax
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.
Peak Plasma Concentration
testosterone AUC
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.
Area under the plasma concentration versus time curve
testosterone T1/2
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.
plasma half-life
anastrozole Cmax
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.
Peak Plasma Concentration
anastrozole AUC
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.
Area under the plasma concentration versus time curve
anastrozole T1/2
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.
plasma half-life
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: The outcome measures will be reported weekly until study completion-3 months
dihydrotestosterone metabolism
Time frame: 3 months
breast elasticity
Time frame: Breast tissue elasticity will be measured by shear wave ultrasound at baseline and on Days 29, 57 and 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N Birrell, Md PhD principal investigator
Wellend Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing testosterone anastrozole in people with Mammographic Density, run by Havah Therapeutics Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
testosterone Cmax (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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.