Healthy adult volunteers under fasting conditions Not Applicable
Conditions
Interventions
The study was conducted in healthy post-menopausal women as a model to avoid the problem of endogenous levels and fluctuations of testosterone in the pharmacokinetics results. Post-menopausal women ha
Sponsors
IBSA Institut Biochimique S.A.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged between 45 and 65 inclusive 2. Post-menopausal status for at least 1 year 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm 5. Endogenous testosterone levels < 3.5 nmol/L (about 1.00 ng/mL) 6. Normal or not clinically relevant abnormal cervical smears at PAP test 7. Normal or not clinically relevant abnormal mammograms 8. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. ECG 12-leads (supine position): clinically relevant abnormalities 2. Clinically relevant abnormal physical findings 3. Clinically relevant abnormal laboratory values 4. Ascertained or presumptive hypersensitivity to the active principle (testosterone) and/or formulations' ingredients 5. Relevant history of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, immunological, dermatological, endocrine, genito-urinary, neurological or psychiatric diseases that could interfere with the aim of the study; malignant neoplasia 6. Intake of any drug affecting the cytochrome P450 for 28 days before the first dose 7. Any hormonal replacement therapy (estrogen-progestin formulations) within 4 weeks, any sex hormone depot injection within 6 months and any sex hormone implants within 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline-corrected rate (Cmax) and extent (AUC0-t) of exposure of total testosterone, free-testosterone and 5a-dihydro-testosterone (DHT) after single dose administration of the test treatments at baseline, 10, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. tmax and baseline-corrected AUC0-8, t1/2, and ?z of total testosterone, free-testosterone and DHT at baseline, 10, 20, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6 and 8 hours post-dose 2. Treatment-Emergent Adverse Events (TEAEs), vital signs (BP, HR), body weight, laboratory parameters (hormones included), ECG after administration of each test treatment. | — |
Countries
Switzerland
Outcome results
None listed