Phase III Study on the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Formulation Applied by a Pen Versus Follitropin Beta Liquid Formulation Applied by Pen
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Convenience and Safety
研究概览
简要总结
This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.
详细描述
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as in-vitro fertilisation (IVF) and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF/intracytoplasmic sperm injection (ICSI) currently includes suppression of endogenous luteinizing hormone (LH) secretion by administration of a gonadotrophin releasing hormone (GnRH) agonist, followed by stimulation of multiple follicular development by exogenous FSH administration. When adequate follicular development is achieved, a single dose of u-hCG (urinary-hCG) is administered to mimic the endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has been shown to be superior to u-hFSH in terms of requiring fewer ampules and more efficacious in terms of number of oocytes recovered and in terms of pregnancy rates.
Recently, a new formulation of follitropin alfa has been developed due to a general trend in the field of therapeutic recombinant proteins to move from presentations based on biological activity to presentations based on physico-chemical characteristics. Until now follitropin alfa has been produced as a powder for injection (either as monodose or multidose preparations) in glass ampoules or in glass vials and administered using plastic or glass syringe. Serono developed a multidose solution for injection in a prefilled disposable injection pen. This study involved comparing the administration of follitropin alfa liquid formulation applied by pen with that of follitropin beta liquid formulation also applied by pen.
OBJECTIVES The objectives of this study were to evaluate the convenience, safety and efficacy of Follitropin alfa (Gonal-f) liquid pen compared with Follitropin beta (Puregon) liquid pen.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-menopausal woman, between her 18th and 39th birthday, receiving recombinant FSH as stimulation for IVF and/or ICSI
- •Subjects who were able to communicate well with the investigator and to comply with the requirements of the entire study
- •Subjects who had given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice
排除标准
- •Subjects who had known allergic reaction against one of the ingredients
- •Subjects with enlarged ovaries or cysts unrelated to polycystic ovaries (PCO)
- •Subjects with gynaecological bleeding of unknown origin
- •Subjects who had ovarian, uterine, or mammary cancer
- •Subjects with tumors of the hypothalamus or the pituitary gland
研究组 & 干预措施
Gonal-f
干预措施: Follitropin alfa liquid formulation (Drug)
Puregon
干预措施: Follitropin beta liquid formulation (Drug)
结局指标
主要结局
Convenience and Safety
时间窗: 1 year
Convenience parameters included nurse/subjects preference; time to train subject; operative tolerance and wastage of product which were assessed during the post-treatment period. Safety parameters included local reactions (pain, bruising, redness, itching, swelling)and adverse drug events which were assessed during the pre-treatment, treatment and post-treatment period.
次要结局
- Efficacy(1 year)