NL-OMON34880已完成不适用
A single blind, randomized, cross-over placebo controlled dose finding study to investigate the pharmacokinetic profile of 3 doses of sublingual testosterone solution and their effect on physiological and subjective arousal in healthy, sexually functional premenopausal women. - PK-PD testosterone
适应症
试验速览
- 阶段
- 不适用
- 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
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of written informed consent;
- •2. Female 21-40 years of age without sexual dysfunction;
- •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. Venous access sufficient to allow blood sampling as per protocol.
排除标准
- •1 Subjects who had used testosterone therapy within 6 months before study entry;
- •2 Use of oral contraception containing anti-androgens (e.g. Diane 35; Minerva);
- •3 Use of oral contraception containing 50 µg estrogen or more;
- •4 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);
- •5 Lactating, or subjects who have given birth in the previous 6 months;
- •6 Subjects who are taking CYP3A4-inhibitors: ritonavir (HIV-proteaseremmer), ketoconazol en itraconazol claritromycine, erytromycine and saquinavir;
- •7 Subjects who are taking CYP3A4-inducers: carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine;
- •8 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.
- •9 Subjects with a peri menopausal hormonal status (FSH > 30).
研究者
相似试验
进行中（未招募）
不适用
A single blind, randomized, cross-over placebo controlled dose finding study to investigate the pharmacokinetic profile of 3 doses of sublingual testosterone solution and their effect on physiological and subjective arousal in healthy, sexually functional premenopausal women. - PK-PD testosteroneThis pharmacokinetic trial will be conducted in healthy women, but it is a part of a developmental program for medicine for Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed)MedDRA version: 12.1Level: HLTClassification code 10040466Term: Sexual arousal disordersMedDRA version: 12.1Level: HLTClassification code 10040470Term: Sexual desire disordersMedDRA version: 12.1Level: HLTClassification code 10040478Term: Sexual dysfunction NECMedDRA version: 12.1Level: LLTClassification code 10020933Term: Hypoactive sexual desire disorderMedDRA version: 12.1Level: LLTClassification code 10037228Term: Psychosexual dysfunction with inhibited sexual desireMedDRA version: 12.1Level: LLTClassification code 10059272Term: Sexual desire decreasedMedDRA version: 12.1Level: LLTClassification code 10040465Term: Sexual arousal decreasedMedDRA version: 12.1Level: LLTClassification code 10058929Term: Disturbance in sexual arousalMedDRA version: 12.1Level: LLTClassification code 10062641Term: Female sexual arousal disorderMedDRA version: 12.1Level: PTClassification code 10058929Term: Disturbance in sexual arousalMedDRA version: 12.1Level: PTClassification code 10062641Term: Female sexual arousal disorderEUCTR2010-019285-86-NLEmotional Brain
已完成
2 期
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.Female Sexual Dysfunctiondecreased libido10013356Hypoactive Sexual Desire DisorderNL-OMON34740Emotional Brain16
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 testosteroneEUCTR2010-019540-39-NLEmotional Brain
进行中（未招募）
不适用
A double blind, randomized, cross-over placebo controlled study to investigate the subjective and physiological efficacy and safety of Lybrido and Lybridos in the domestic setting in healthy female subjects with Female Sexual Dysfunction in combination with SSRI use. - Lybrido(s) and SSRIs@HomeHypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed) and/or SSRI induced sexual dysfunctioning.EUCTR2009-016790-15-NLEmotional Brain
进行中（未招募）
不适用
A class-room experiment to investigate the genetic differences regarding effects of metoprolol in human volunteersInfluence of CYP2D6 polymorphism on metoprolol pharmacokinetics and pharmacodynamics in human volunteersMedDRA version: 18.0Level: HLGTClassification code 10007521Term: Cardiac arrhythmiasSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: PTClassification code 10015488Term: Essential hypertensionSystem Organ Class: 10047065 - Vascular disordersEUCTR2015-002265-36-NLCentre for Human Drug Research