Bioavailability study of a new testosterone orodispersible tablet (ODT) administered as single doses of 6 and 12 mg to healthy postmenopausal women. Single dose, open, randomised, 3-period, 3-way cross-over exploratory bioavailability study

IBSA Institut Biochimique S.A.0 sites16 target enrollmentStarted: October 16, 2015Last updated: November 16, 2020

Conditions

Trial Snapshot

No summary available.

•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

•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

Sponsor

IBSA Institut Biochimique S.A.