Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT03264651
Eligibility Criteria:
Inclusion Criteria:
* Provision of written informed consent
* Pre-menopausal levels of FSH/LH/E2 (follicle stimulating hormone, luteinizing hormone, oestrogen) according to the definition of "pre-menopausal range" for the laboratory involved
* Have a Volpara Density volumetric breast density of \>15.5% (combined average both breasts)
* Breast pain in the previous month of equal to or greater than 40mm on a 100mm visual analogue pain scale
* WBC ≥ 3.0 x 109/L, granulocytes ≥ 1.5 X 109/L and platelets ≥ 100 x 109/L.
* AST/SGOT or ALT/SGPT ≤ 3 times ULN
* eGFR\> 60 ml/min/1.73m2
* Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment;
* For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception during and for at least 6 months after completion of study treatment; 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 sterilization) during and for at least 6 months after completion of study treatment;
Exclusion Criteria:
* Presence of breast cancer
* Diabetes mellitus or glucose intolerance defined as a fasting glucose \>6mmol/l
* Previous or concomitant other (non-breast cancer) malignancy within the previous 5 years (other than skin cancer)
* History of coronary artery disease
* Systemic hormonal contraception
* Risk of transmitting Human Immunodeficiency Virus or viral hepatitis via infected blood
* Known hypersensitivity to any component of testosterone
* Unable to comply with study requirements
* Prolonged systemic corticosteroid treatment
* Any investigational drugs
* Systemic hormone replacement therapy
* Pregnant or lactating women
* Known liver disease
* Current warfarin usage
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03264651
Study Brief:
Protocol Section:
NCT03264651