EUCTR2008-000201-11-ES进行中（未招募）不适用
Ensayo piloto randomizado, doble-ciego, en grupos paralelos, placebo-controlado, monocéntrico evaluando la tolerabilidad de la quinagolida 200mcg/día en un régimen de aumento de dosis en donantes de ovocitos con riesgo para el desarrollo del síndrome de hiperestimulación ovárico - Tolerabilidad de la quinagolida en dosis crecientes en donantes de ovocitos con riesgo para SHO
适应症
相关药物
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.Signed Informed Consent Form, prior to screening evaluations
- •2.In good physical and mental health
- •3.Pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation
- •4.Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
- •5.Oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (ART)
- •6.Antral follicle count = 20
- •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.Any exclusion criteria for oocyte donation
- •2.Known clinically significant systemic disease (e.g., insulin dependent diabetes)
- •3.Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
- •4.Undiagnosed vaginal bleeding
- •5.Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
- •6.Malformations of the sexual organs incompatible with pregnancy
- •7.Positive pregnancy test prior to start of stimulation
- •8.Treatment with other dopamine agonists (ATC code N04BC) or dopamine antagonists (ATC code N05A) within 2 months prior to randomisation
- •9.Treatment with any hormonal therapy (except for thyroid medication and oral contraceptives and except that routinely used as part of the controlled ovarian hyperstimulation cycle), anti-psychotics (ATC code N05A), anti-depressants (ATC code N06), anxiolytics (ATC code N05B), hypnotics and sedatives (ATC code N05C) or continuous use of prostaglandin inhibitors (non-steroid anti-inflammatory drugs (NSAIDs), including aspirin) within 2 weeks prior to randomisation
- •10.Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •11.Known history of psychotic disorders
- •12.Hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation
- •13.Ongoing treatment of hypertension
- •14.Known previous poor tolerability to dopamine agonists
- •15.Known impaired hepatic or renal function
- •16.Current or past (12 months prior to randomisation) abuse of alcohol or drugs, and/or current (last month prior to randomisation) use of alcohol (more than 14 units per week)
- •17.Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day
- •18.History of chemotherapy (except for gestational conditions) or radiotherapy
- •19.Use of any investigational drug during 3 months prior to randomisation
- •20.Previous participation in the study
- •Hypersensitivity to the active substance or to any of the excipients
研究者
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