NCT00665041已完成2 期
A Randomised, Double-blind, Parallel Groups, Placebo-controlled, Single-centre Pilot Study Assessing the Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome
Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS
研究概览
简要总结
Assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS Secondary Objectives
Estimate the effects of a quinagolide dose-titration regimen compared to placebo in peritoneal fluid accumulation, incidence of ascites, OHSS symptoms and clinical laboratory parameters of haemoconcentration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form, prior to screening evaluations
- •In good physical and mental health
- •Pre-menopausal females between the ages of 21-34 years (both inclusive) at the time of randomisation
- •Body mass index (BMI) between 18 and 29 kg/m2 (both inclusive)
- •Oocyte donor currently undergoing a controlled ovarian hyperstimulation cycle for assisted reproductive technologies (ART)
- •Antral follicle count ≥ 20
排除标准
- •Any exclusion criteria for oocyte donation
- •Known clinically significant systemic disease (e.g., insulin dependent diabetes)
- •Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the study
- •Undiagnosed vaginal bleeding
- •Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
- •Malformations of the sexual organs incompatible with pregnancy
- •Positive pregnancy test prior to start of stimulation
- •Treatment with other dopamine agonists (ATC code N04BC) or dopamine antagonists (ATC code N05A) within 2 months prior to randomisation
- •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
- •Known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Known history of psychotic disorders
- •Hypotension, orthostatic hypotension or recurrent syncope within 6 months prior to randomisation
- •Ongoing treatment of hypertension
- •Known previous poor tolerability to dopamine agonists
- •Known impaired hepatic or renal function
- •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)
- •Current or past (3 months prior to randomisation) smoking habit of more than 20 cigarettes per day
- •History of chemotherapy (except for gestational conditions) or radiotherapy
- •Use of any investigational drug during 3 months prior to randomisation
- •Previous participation in the study
- •Hypersensitivity to the active substance or to any of the excipients
研究组 & 干预措施
PR1
Experimental
干预措施: Quinagolide (Drug)
PL1
Placebo Comparator
干预措施: Quinagolide (Drug)
结局指标
主要结局
To assess the tolerability of quinagolide 200 μg/day in a dose-titration regimen in oocyte donors undergoing controlled ovarian hyperstimulation and at risk of developing OHSS
时间窗: 21 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)Heart FailureNCT01951625Bayer456
已完成
2 期
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure and Preserved Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-PRESERVED)Heart FailureNCT01951638Bayer477
终止
2 期
A Study To Evaluate PF-00915275 In Subjects With Type 2 Diabetes Mellitus For 4-WeeksDiabetes Mellitus, Type 2NCT00427401Pfizer40
已完成
1 期
Study of Multiple-dose Kukoamine B Mesilate in Healthy VolunteersHealthyNCT02690961Tianjin Chasesun Pharmaceutical Co., LTD24
已完成
1 期
Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIBN 4096 BS in Healthy Male and Female VolunteersHealthyNCT02194335Boehringer Ingelheim32