Bioavailability study of a new testosterone tablet formulation administered as single doses of 1, 2 and 3 mg to healthy postmenopausal wome
- Conditions
- Testosterone hydroxypropyl-ß-cyclodextrin (HPBCD), 1 mg and 2 mg tabletsNot Applicable
- Registration Number
- ISRCTN46559299
- Lead Sponsor
- IBSA Institut Biochimique SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 16
1. Informed consent: signed written informed consent prior to inclusion in the study
2. Menopause: postmenopausal women for at least one year
3. Age: 45-65 year old inclusive
4. Body Mass Index (BMI) from 18.5 to 30 kg/m2
5. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
6. Testosterone levels: endogenous testosterone levels <3.5 nmol/L (about 1.00 ng/mL)
7. Pap test: normal or not clinically relevant abnormal cervical smears at Papanicolaou test performed within the last 12 months or during the screening phase
8. Mammography: normal or not clinically relevant abnormal mammograms at mammography performed within the last 24 months or during the screening phase
9. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
1. Electrocardiogram (ECG) 12-leads (supine position): clinically relevant abnormalities
2. Physical findings: clinically relevant abnormal physical findings which could interfere with the objectives of the study
3. Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness
4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considered could affect the outcome of the study
5. Diseases: relevant history of cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, immunological, dermatological, endocrine (e.g. hyper-prolactinemia or uncontrolled thyroid and adrenal dysfunction), genitourinary, neurological or psychiatric diseases that could interfere with the aim of the study; malignant neoplasia
6. Medications: intake of other medications, including over the counter medications and herbal remedies, for 2 weeks before the start of the study. Intake of any drug affecting the cytochrome P450 for 28 days before the start of the study
7. Hormonal replacement therapy: 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 before the start of the study
8. Investigative drug trials: participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
9. Blood donation: blood donations for 3 months before this study
10. Drug, tobacco, alcohol, caffeine: history of drug, alcohol (>1 drink/day, defined according to USDA Dietary Guidelines 2015-2020), caffeine (>5 cups coffee/tea/day) or tobacco (?10 cigarettes per day ) abuse
11. Diet: abnormal diets (<1600 or >3500 kcal/day) or substantial changes in eating habits in the 4 weeks before the start of this study; vegetarian
12. Pregnancy test: positive urine pregnancy test at screening
13. Drug test: positive abuse drug test at screening
14. Alcohol breath test: positive alcohol breath test at day -1
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total testosterone, free testosterone and DHT rate (Cmax) and extent (AUC0-t) of absorption after single dose administration of the test treatments. The concentration of testosterone, DHT, albumin, SHBG was measured in serum at the following time-points: pre-dose (0), 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 5, 6 and 8 h post-dose.
- Secondary Outcome Measures
Name Time Method 1. Serum pharmacokinetic parameters for total testosterone, free-testosterone and DHT after single dose of the test treatments. The concentration of testosterone, DHT, albumin, SHBG was measured in serum at the following time-points: pre-dose (0), 10, 20, 30, 45 min, 1, 1.5, 2, 3, 4, 5, 6 and 8 h post-dose.<br>2. Safety of the test treatments, assessed throughout the study