An Open-label, Single Center Trial to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Org 36286 After a Single Subcutaneous Dose in Healthy Female Volunteers Whose Pituitary Function is Suppressed by Lyndiol®.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Mean total plasma clearance (CL) post single dose Org 36286
研究概览
简要总结
The objectives of this study were to study the pharmacokinetics, pharmacodynamics and safety of Org 36286 after a single subcutaneous administration in healthy females.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Good physical and mental health;
- •Body Mass Index between 18 and 29 kg/m^2;
- •Good venous accessibility;
排除标准
- •Clinically relevant abnormal blood chemistry, hematology and/or urinalysis at screening;
- •Hypertension (sitting diastolic blood pressure > 90 mmHg and/or systolic blood pressure > 150 mmHg);
- •Contraindications for the use of oral contraceptives or gonadotropins;
- •PAP-smear (= III) according to the Papanicolaou classification;
- •History of endocrine abnormalities such as hyperprolactinaemia, polycystic ovary syndrome or any evidence of ovarian dysfunction;
- •Primary ovarian failure;
- •Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease;
- •Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation;
- •Ovarian surgery;
- •Smoking more than 10 cigarettes or equivalents a day;
- •History (within 12 months) of alcohol or drugs abuse;
- •Blood donation (> 200 ml) within 90 days prior to screening;
- •Administration of investigational drugs within 90 days prior to start Org 36286.
研究组 & 干预措施
Org 36286 15 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg.
干预措施: Org 36286 (Drug)
Org 36286 15 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 15 μg.
干预措施: Lyndiol® (Drug)
Org 36286 30 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg.
干预措施: Org 36286 (Drug)
Org 36286 30 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 30 μg.
干预措施: Lyndiol® (Drug)
Org 36286 60 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg.
干预措施: Org 36286 (Drug)
Org 36286 60 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 60 μg.
干预措施: Lyndiol® (Drug)
Org 36286 120 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg.
干预措施: Org 36286 (Drug)
Org 36286 120 μg + Lyndiol®
After a pill-free period of 7 days, participants took 1 oral tablet of Lyndiol® (50 μg ethinylestradiol + 2.5 mg lynestrenol) daily for a total period of at least 6 weeks to suppress endogenous gonadotropin secretion. After 3 weeks of Lyndiol® intake, participants received a single subcutaneous dose of Org 36286 120 μg.
干预措施: Lyndiol® (Drug)
结局指标
主要结局
Mean total plasma clearance (CL) post single dose Org 36286
时间窗: Days 1 - 15
Maximum number of follicles >= 5 mm (nmax)
时间窗: Days 2 - 35
Number of participants with an adverse event (AE)
时间窗: Start of treatment up to day 28
Mean dose-normalized area under the curve (AUC) post single dose Org 36286
时间窗: Days 1 - 15
Mean dose-normalized maximum plasma concentration (Cmax) post single dose Org 36286
时间窗: Days 1 - 15
次要结局
- Day on which the number of follicles >= 5 mm was equal to nmax for the first time (dmax)(Days 2 - 35)
- Total number of follicles >= 5 mm per day(Days 2 - 35)