NCT01872078已完成2 期
A Randomised, Double-blind, Placebo-controlled Phase IIa Study to Assess the Pharmacodynamics, Safety, and Pharmacokinetics of AZD4901 When Given in Multiple Doses to Females With Polycystic Ovary Syndrome
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
- AstraZeneca
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7
研究概览
简要总结
To assess the effects of AZD4901 when given in multiple doses to females with Polycystic Ovary Syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patients between the ages of 18 to 45 years (inclusive). Suitable veins for cannulation or repeated venipuncture. Body mass index (BMI) between 18 and 40 kg/m2 (inclusive). A diagnosis of polycystic ovary disease. Amenorrhea or oligomenorrhea (defined as ≤ 6 menses per year). Negative serum pregnancy test at screening. Negative urine pregnancy test before randomisation. Not be breast-feeding. Not have been pregnant within the 6 months prior to screening.
排除标准
- •Perimenopausal or reached natural menopause, defined as FSH > 10 IU/L. Menstruated within the month prior to the baseline visit. Hysterectomy or bilateral oophorectomy or both. Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding.
- •Withdrawals from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit.
研究组 & 干预措施
AZD4901 20 mg once a day
Experimental
AZD4901 20 mg once a day
干预措施: AZD4901 (oral) (Drug)
AZD4901 20mg twice a day
Experimental
AZD4901 20mg twice a day
干预措施: AZD4901 (oral) (Drug)
AZD4901 40 mg twice a day
Experimental
AZD4901 40 mg twice a day
干预措施: AZD4901 (oral) (Drug)
Placebo to match AZD4901
Experimental
干预措施: Placebo to match AZD4901 (Drug)
结局指标
主要结局
Lutenising Hormone (LH) AUC(0-8) Ratio to Baseline at Day 7
时间窗: Day 7
Change-from-baseline of luteinising hormone area under the concentration-time curve from time zero to 8 hours postdose \[AUC(0-8)\] at Day 7
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Effect of Vitamin D on Hormonal, Metabolic and Cardiovascular Risk Factors in Patients With Polycystic Ovary SyndromePolycystic Ovary SyndromeNCT02513381Hull University Teaching Hospitals NHS Trust40
已完成
2 期
A Study to Assess the Efficacy and Safety of Multiple Dose Levels of AZD7594 Administered Once Daily by Inhalation in Asthmatic SubjectsAsthmaNCT03622112AstraZeneca808
已完成
2 期
A Trial to Evaluate OPC 67683 in Participants With Pulmonary Sputum Culture-positive, Multidrug-resistant Tuberculosis (TB)Tuberculosis, PulmonaryTuberculosis, Multidrug ResistantExtensively Drug-Resistant TuberculosisNCT00685360Otsuka Pharmaceutical Development & Commercialization, Inc.481
已完成
2 期
Study to Assess the Efficacy and Safety of AZD1981 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Moderate to Severe COPDNCT00690482AstraZeneca118
撤回
1 期
AZD6765 Oral Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)HealthyNCT00963365AstraZeneca