EUCTR2012-003543-30-NL进行中（未招募）不适用
A double-blind, randomized, placebo-controlled, proof of concept study to investigate the differences between the combined administration of 0.5 mg sublingual testosterone and 10 mg buspirone and 10 mg buspirone administration alone in women with hypoactive sexual desire disorder - EB93 PoC
适应症
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
- •1.Provision of written informed consent.
- •2.Female 21 – 70 years of age with Hypoactive Sexual Desire Disorder (comorbidity with other sexual dysfunctions e.g Female Sexual Arousal Disorder (FSAD) is allowed). The diagnosis will be made by an experienced psychologist/sexologist.
- •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 irrelevant.
- •4.Subjects must have a heterosexual relationship.
- •5.Be involved in a stable relationship and have a partner who will be accessible during the 3-week at home period.
- •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 9
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Cardiovascular conditions
- •1.Any underlying cardiovascular condition, including unstable angina pectoris
- •2.Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg.
- •3.Systolic blood pressure < 90 mmHg and/or diastolic blood pressure <50 mmHg
- •Gynecological and obstetric conditions
- •4.Use of oral contraceptive containing anti-androgens (e.g. Crypteron acetate) or (anti)androgenic progestogens (drospirone, dienogest, chlormadinone acetate and norgestrel)
- •5.Use of oral contraceptive containing 50 µg estrogen or more
- •6.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.)
- •7.Lactating or delivery in the previous 6 months
- •8.Unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- •9.Subjects with a perimenopausal hormonal status (follicle-stimulating hormone>40)
- •Other medical conditions
- •10.Liver- and/or renal insufficiency
- •11.Current clinically relevant endocrine disease
- •12.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 buspirone and/or testosterone use
- •13.(A history of) hormone-dependant malignancy
- •14.Vision impairment, such as partial or complete blindness or color blindness
- •15.Dyslexia
- •16.Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
- •Psychological/psychiatric factors
- •17.History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
- •18.(Psychotherapeutic and/or pharmacological treatment for) a psychiatric disorder that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for buspirone and/or testosterone use
- •19.Current psychotherapeutic treatment for female sexual dysfunction
- •20.Current sexual disorder of vaginismus or dyspareunia according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (text revision (DSM IV TR))
- •21.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 12 hours before the Stroop task).
- •22.Positive test result for illicit drugs
- •Concomitant medication
- •23.Subjects who are taking CYP3A4-inhibitors (eg, ritonavir, ketoconazol, itraconazol claritromycine, erytromycine and saquinavir)
- •24.Subjects who are taking CYP3A4-inducers (eg, carbamazepine, fenytoïne, fenobarbital, st Johns Wort, rifampicine)
- •25.Use of serotonergic drugs (eg, trazodon, fluvoxamine), tricyclic antidepressants or other antidepressants
- •26.Use of testosterone therapy within 6 months before study entry
- •27.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), triptans)
- •28.Illiteracy, unwillingness, or inability to follow study procedures
- •29.Any other clinically significant abnormality or condition which, in the opinion of investigator, might interfere with the p
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