ISRCTN46559299已完成未知
Bioavailability study of a new testosterone tablet formulation administered as single doses of 1, 2 and 3 mg to healthy postmenopausal women
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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