EUCTR2013-000788-98-GB进行中（未招募）1 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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
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
入选标准
- •Female patients between the ages of 18 to 45 years (inclusive) with 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 oligomenorrrhea (defined as = 6 menses per year)
- •-Females must have a negative serum pregnancy test at screening and a negative urine pregnancy test before randomisation, must not be breast-feeding, must not have been pregnant within the 6 months prior to screening
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Is perimenopausal or has reached natural menopause, defined as FSH > 10 IU/L
- •-Has menstruated within the month prior to the baseline visit
- •-Patients who have had a hysterectomy or bilateral oophorectomy or both
- •-Clinically relevant disease and abnormalities (past or present), and in particular causes of abnormal vaginal bleeding
- •-Patients who are withdrawing from oral contraceptives if their LH levels are below 3 IU/L when retested within 7 ± 1 days of the baseline visit
研究者
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