EUCTR2010-019540-39-NL进行中（未招募）不适用
A double blind, randomized, cross-over placebo controlled study to investigate the efficacy of sublingual testosterone solution on physiological and subjective arousal in healthy, sexually dysfunctional premenopausal women. - PD testosterone
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Sixteen (16) healthy premenopausal women with HSDD:
- •1. Provision of written informed consent;
- •2. Female 21-40 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed).
- •3. Healthy according to normal results of medical history, physical examination, laboratory values and vital signs, unless the investigator considers an abnormality to be clinically relevant;
- •4. Subject must be heterosexually oriented;
- •5. BMI = 18 and = 30 kg/m2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of Childhood Sexual Abuse
- •2. Sexual dysfunction as determined SFQ diagnostic scores (within ‘high probability of dysfunction’ or ‘possibility of dysfunction’ ranges) for all functional domains (desire, arousal-lubrication, arousal-sensation, orgasm and pain) as described by Quirk et al. 2005;
- •3. Subjects who had used testosterone therapy within 6 months before study entry;
- •4. (A history of) hormone-dependant malignancy ;
- •5. Use of oral contraception containing anti-androgens (e.g. Diane 35; Minerva);
- •6. Use of oral contraception containing 50 µg estrogen or more;
- •7. Pregnancy, or intention to become pregnant during this study (Note: a serum or urine pregnancy test will be performed in all women prior to the administration of study medications);
- •8. A pelvic inflammatory disease or an untreated vaginal infection at screening;
- •9. Lactating, or subjects who have given birth in the previous 6 months;
- •10. Previous prolapse and incontinence surgery affecting the vaginal wall, which in the opinion of investigator would interfere with the VPA measurement;
- •11. Women with other unexplained gynecological complaints, such as abnormal uterine bleeding patterns;
- •12. (History of) endocrine disease;
- •13. (History of) severe neurological problems, current severe neurological problems, or other mild or moderate neurological problems which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if she took part in the trial;
- •14. Treatment for a current serious psychiatric disorder (e.g., schizophrenia, psychosis ) or treatment for obsessive compulsive disorder, anorexia nervosa, bulimia nervosa and/or social anxiety neurosis.
- •15. Any underlying cardiovascular condition including unstable angina pectoris, that would preclude sexual activity;
- •16. (History of) myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months;
- •17. Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 60-80 bpm in rest, > 90-115 bpm in moderate exercise), or other significant abnormality observed on ECG;
- •18. Systolic blood pressure = 130 mmHg and/or diastolic blood pressure > 80 mmHg;
- •19. Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;
- •20. Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;
- •21. Acute/chronic liver disease: ASAT and ALAT > 3x the upper limit of normal;
- •22. Renal insufficiency (< 29 ml/min): based on the Cockcroft and Gault formula;
- •23. 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 moderately alcohol drinking behavior is allowed, only 12 hours before the experimental days is alcohol drinking not allowed. Three weeks before the start of the experimental day is the taking of any recreational drug not allowed. Smoking is allowed.
- •24. Subjects who are illiterate, unwilling or unable to understand and complete the questionnaires;
- •25. Any other clinically significant abnormality or condition which in the opinion of investigator would interfere with the participant’s ability to provide informed consent, comply with study instructions, possibly confoun
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