A Double-blind, Randomized, Dose-controlled Study to Evaluate Pharmacodynamic Properties of Four Oral Doses of Dienogest (DNG) in 100 Healthy Young Female Volunteers Over a Period of Two Cycles up to a Maximum of 72 Days
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 102
- 主要终点
- No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
研究概览
简要总结
This study will be investigated what mechanism of action Dienogest has. The growth of the follicles, the endometrium, the hormones in the blood and the mucus that is produced by the cervix that will be looked upon. Four different dosages of Dienogest (0.5 mg, 1 mg, 2 mg and 3 mg) will be investigated in healthy young women over two cycles, or up to a maximum of 72 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body-Mass-Index (BMI): 18 - 30 kg/m²
- •Healthy female volunteers
- •Age 18-35 years (smoker not older than 30 years, inclusive)
- •At least 3 months since delivery, abortion or lactation
- •Willingness to use non-hormonal methods of contraception during entire study
排除标准
- •Contraindications for use of progesterone-only pills or combined oral contraceptives (e.g. history of venous/arterial thromboembolic disease)
- •Use of systemic or topical medications or substances which oppose the study objectives or which might influence them within 4 weeks prior to start of the pre-treatment cycle
- •Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
研究组 & 干预措施
Arm 1
干预措施: Dienogest (81150037) (Drug)
Arm 2
干预措施: Dienogest (81150231) (Drug)
Arm 3
干预措施: Dienogest (SH T00660A) (Drug)
Arm 4
干预措施: Dienogest (81150746) (Drug)
结局指标
主要结局
No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
时间窗: No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned
次要结局
- Concentrations of DNG in serum(During pre-treatment and treatment cycles (3 months))
- Endometrial thickness(During pre-treatment and treatment cycles (3 months))
- Effects on the cervix and the cervical mucus(During pre-treatment and treatment cycles (3 months))
- Course of gonadotropins (FSH, LH, P, E2)(During pre-treatment and treatment cycles (3 months))
- mRNA expression profile of endometrial biopsies and in blood(once in pre-treatment and during treatment)
- Safety and tolerability(During pre-treatment and treatment cycles (3 months))
- Grading of ovarian activity(During pre-treatment and treatment cycles (3 months))