EUCTR2013-001966-40-NL进行中（未招募）不适用
A double blind, randomized, placebo controlled, cross-over, Lybridos dose finding study to validate the predictive power of the diagnostic model for Lybrido and Lybridos efficacy and to identify and evaluate additional psychometric and biological markers which increase the predictive power of the diagnostic model, in women with hypoactive sexual desire disorder with or without sexual arousal disorder and/or female orgasmic disorder or SSRI induced sexual dysfunction, in the domestic situation.
Companion Diagnostics BV0 个研究点开始时间: 2013年6月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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.Females between 18 and 70 years of age, inclusive, pre or postmenopausal, with HSDD or SSRI induced sexual dysfunction (comorbidity with female sexual arousal disorder [FSAD] and/or female orgasmic disorder [FOD]; only as secondary diagnosis) is allowed. The diagnosis of HSDD or SSRI induced sexual dysfunction will be established by a trained health care professional
- •3.Be involved in a stable, communicative, monogamous relationship and have a sexually functional partner who will be at home for the majority of the study duration
- •4.Healthy with normal medical history, physical examination, laboratory values, and vital signs; exceptions may be made if the investigator considers an abnormality to be clinically irrelevant
- •5.Use of highly effective contraception
- •6.For women who use SSRI: usage of an SSRI for the treatment of anxiety disorders or depression (not for, for example, anorexia nervosa or obsessive compulsive disorder) for a minimum of 3 months and on a stable dose for at least 6 weeks before screening. The following dosage ranges are allowed: Prozac (fluoxetine) 20-80 mg/day; fluvoxamine 100-300 mg/day; Zoloft (sertraline) 50-200 mg/day; Paxil (paroxetine) 20-60 mg/day; Celexa (citalopram) 20-40 mg/day; Lexapro (escitalopram) 10-30 mg/day
- •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 205
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Any underlying cardiovascular condition, including unstable angina pectoris, that would preclude sexual activity
- •2.Systolic blood pressure = 140 mmHg and/or diastolic blood pressure = 90 mmHg (supine blood pressure). For subjects = 60 years old and without diabetes mellitus, familial hypercholesterolemia, or cardiovascular disease: systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 90 mmHg
- •3.Systolic blood pressure = 90 mmHg and/or diastolic blood pressure = 50 mmHg (supine blood pressure).
- •4.Use of any contraceptive containing anti-androgens or (anti)androgenic progestogens (drospirenone, dienogest, chlormadinone acetate and norgestrel)
- •5.Use of any contraceptive or hormone replacement therapy (HRT) containing more than 50 µg/day of estrogen
- •6.Pregnancy or intention to become pregnant during this study
- •7.Lactating or delivery in the previous 6 months prior to signing Informed Consent Form
- •8.History of bilateral oophorectomy
- •9.Other unexplained gynecological complaints, such as clinically relevant abnormal uterine bleeding patterns
- •10.Perimenopausal status (cycle shortening/irregular menstrual bleeding in the last 12 consecutive months and/or occurrence of vasomotor symptoms and/or FSH levels (>40 IU/L) for women from age 40 onwards; in women with a history of hysterectomy perimenopausality can be assessed by FSH levels (> 40 IU/L) and/or vasomotor symptoms)
- •11.Liver and/or renal insufficiency (aspartate aminotransferase, alanine aminotransferase and gamma glutamyltransferase > 3 times the upper limit of normal and/or estimated glomerular filtration rate (eGFR) < 60.00 mL/min based on the Cockcroft Gault formula)
- •12.Any current endocrine disease or endocrinopathy as determined by medical history, basic physical examination and/or laboratory values significantly outside normal range of the central laboratory; or uncontrolled diabetes mellitus(HbA1c > 7.5%)
- •13.Free- and/or total testosterone levels outside the upper limit of the reference range of the central laboratory (free testosterone: > 1.1 ng/dL, and total testosterone > 80 ng/dL)
- •14.Any current clinically relevant neurological disease which, in the opinion of the investigator, would compromise the validity of study results or which exclude from use of sildenafil, buspirone and/or testosterone
- •15.History of hormone dependent malignancy (including all types of breast cancer)
- •16.Positive test result for immunodeficiency virus, hepatitis B, or hepatitis C (acute and chronic hepatitis infection)
- •17.History of serotonin syndrome
- •Psychological/Psychiatric Factors
- •18.History of (childhood) sexual abuse that, in the opinion of the investigator, could result in negative psychological effects when testosterone is administered
- •19.(Psychotherapeutic and/or pharmacological treatment for) a psychiatric disorder (other than those under inclusion criterion 6) that, in the opinion of the investigator, would compromise the validity of study results or which could be a contraindication for sildenafil, buspirone and/or testosterone use
- •20.Current psychotherapeutic treatment for female sexual dysfunction
- •21.Current sexual disorder of vaginismus or dyspareunia according to the DSM IV TR, Anorgasmia with a lifelong inability to reach an orgasm
- •22.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
- •23.For women who use
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