NCT01183143已完成3 期
A Multicentre, Open-label, Non-comparative Phase IIIb Study to Evaluate the Acceptability of GONAL-f® Prefilled Liquid Formulation Administered by Pen in an Outpatient Setting for Ovarian Stimulation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)
研究概览
简要总结
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged between 18 and 43 years
- •Ambulatory subjects
- •Subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures
- •Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
- •Subjects who have given written informed consent, prior to treatment
排除标准
- •Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries
- •Subjects with extra-uterine pregnancy during the last 3 months
- •Subjects with several endometriosis (Grade III & IV)
- •Subjects with history of severe ovarian hyperstimulation syndrome
- •Subjects with history of thromboembolic event
- •Subjects with malformative uterine pathology that could disturb either implantation or pregnancy processes
- •Subjects with premature menopause
- •Subjects with gynecological bleeding of unknown origin
- •Subjects with ovarian, uterine, or mammary cancer
- •Subjects with tumors of the hypothalamus or the pituitary glands
- •Subjects with history of serious allergy or atopic asthma disease
- •Subjects with known allergic reaction against one of the Follicle Stimulating Hormone (FSH) and ingredients,
- •Ongoing pregnant, or breast feeding subjects
- •Subjects who have participated in a trial during the last 3 months
研究组 & 干预措施
GONAL-f®
Experimental
干预措施: GONAL-f® (Drug)
结局指标
主要结局
Number of Subjects Who Self-administered the Investigational Medicinal Product (IMP)
时间窗: Up to 1 year
Number of subjects who self-administered the IMP were presented in this outcome measure.
次要结局
- Global Evaluation of the GONAL-f® Prefilled Pen by the Investigator(Up to 1 year)
- Evaluation of the Information Given to the Subjects on the Pen's Utilization(Up to 1 year)
- Duration of Ovarian Stimulation With GONAL-f®(Up to 1 year)
- Mean Number of Embryos Transferred(End of Stimulation period (up to a maximum 26 days))
- Total and Average Daily Dose of GONAL-f®(Up to 26 days)
- Pregnancy Rate in Subjects Receiving Stimulation by Ovulation Induction (OI) or Artificial Insemination (IUI)(Up to 20 Weeks of Gestation)
- Number of Subjects With Live Birth(End of Gestation period, assessed up to a maximum of 1 year)
- Number of Subjects With Local Tolerance at GONAL-f ® Injection Site as Assessed by Investigator(Up to 1 year)
- Number of Subjects With at Least 1 Adverse Event(Up to 1 year)
- Number of Subjects Taking at Least 1 Concomitant Treatment(Up to 1 year)
研究者
研究点 (1)
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