NL-OMON36050已完成不适用
A randomized, cross-over controlled study to compare the pharmacokinetic profiles of sublingual administered testosterone solution followed by a sildenafil citrate tablet, versus sublingual testosterone and sildenafil citrate combined in one tablet in healthy premenopausal women - PK - Lybrido Formulations 1 and 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of written informed consent
- •2. Female 18-35 years of age
- •3. Healthy based on medical history, physical examination, laboratory values and vital signs
- •4. Body mass index (BMI) >= 18 kg/m2 and <= 30 kg/m2
- •5. Venous access sufficient to allow blood sampling as per protocol
排除标准
- •Cardiovascular conditions
- •1. Any underlying cardiovascular condition, including unstable angina pectoris
- •2. History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months
- •3. Uncontrolled atrial fibrillation/flutter at screening, or other significant abnormality observed on electrocardiogram (ECG)
- •4. Systolic blood pressure >= 140 mmHg and/or diastolic blood pressure > 90 mmHg.
- •5. Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg;Gynecological and obstetric conditions
- •6. Use of oral contraceptive containing anti-androgens
- •7. Use of oral contraceptive containing estrogen or more
- •8. Pregnancy or intention to become pregnant during this study (Note: An urine pregnancy test will be performed in all women prior to the administration of study medications.)
- •9. Lactating or delivery in the previous 6 months
- •10. Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- •11. Subjects with a perimenopausal hormonal status (follicle-stimulating hormone>30);Other medical conditions
- •12. Liver- and/or renal insufficiency
- •13. Current clinically relevant endocrine disease
- •14. Current clinically relevant neurological disease which, in the opinion of investigator, would compromise the validity of study results, or which could form a contraindication for sildenafil and/or testosterone use
- •15. (A history of) hormone-dependant malignancy;Psychological/psychiatric factors
- •16. A substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject*s participation in the study; mild or moderate alcohol consumption is allowed but must be stopped 24 hours before the experimental visit. Recreational drug use is not allowed beginning 3 weeks before the start of the experimental visit until follow up. Smoking is not allowed. ;Concomitant medication
- •17. Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir)
- •18. Subjects who are taking CYP3A4-inducers (eg, carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine)
- •19. Use of nitrates or nitric oxide donor compounds
- •20. Use of any other medication that interferes with study medication (eg, monoamine oxidase (MAO) inhibitors (includes classic MAO inhibitors and linezolid), calcium channel blockers (eg, diltiazem and verapamil), use of corticosteroids)
- •21. Use of testosterone therapy within 6 months before study entry;Drug/food interaction
- •22. Consumption of grapefruit or grapefruit-containing foods throughout the duration of the study;General
- •23. Illiteracy, unwillingness, or inability to follow study procedures
- •24. Any other clinically significant abnormality or condition which, in the opinion of investigator, might interfere with the participant*s ability to provide informed consent or comply with study instructions, compromise the validity of study results, or be a contraindication for sildenafil and/or testosterone use.
- •25. Participation in any other clinical drug study in the previous 3 months.
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