A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch (Lutrepatch) Compared to Oral Treatment With Clomiphene Citrate or Placebo in Anovulatory or Oligoovulatory Infertile Females
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 35
- 主要终点
- Ovulation rate
研究概览
简要总结
The primary objective of this study is to determine the safety and efficacy of pulsatile GnRH delivered from a iontophoretic patch (Lutrepatch) for induction of ovulation in women with anovulatory/ oligoovulatory infertility, compared to placebo and to a reference treatment with clomiphene citrate.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females between the ages of 18 and 38 years
- •Desire to become pregnant
- •Infertile due to ovulatory dysfunction as described below:
- •Unable to conceive for at least 1 year and
- •Anovulatory (defined as 4 or fewer menstrual cycles per year) or Oligo-ovulatory (defined as menstrual cycle frequency > 45 days)
排除标准
- •Requires donor oocytes or sperm
- •Two or more failed (defined as no biochemical pregnancy achieved) gonadotropin fertility treatment cycles - if previous gonadotropin success, no more than two failed subsequent cycles
- •Use of insulin-sensitizing drugs (e.g., Metformin) within 1 month prior to progesterone challenge
研究组 & 干预措施
GnRH High Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: GnRH iontophoretic transdermal Lutrepatch (Drug)
GnRH High Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: placebo clomiphene citrate (Drug)
GnRH Medium Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a medium target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: GnRH iontophoretic transdermal Lutrepatch (Drug)
GnRH Medium Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a medium target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: placebo clomiphene citrate (Drug)
GnRH Low Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a low target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: GnRH iontophoretic transdermal Lutrepatch (Drug)
GnRH Low Target Delivery
10 mg GnRH iontophoretic transdermal Lutrepatch with a low target delivery of pulsatile GnRH (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: placebo clomiphene citrate (Drug)
Clomiphene Citrate
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral 50 mg clomiphene citrate for 5 days
干预措施: clomiphene citrate (Drug)
Clomiphene Citrate
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral 50 mg clomiphene citrate for 5 days
干预措施: placebo GnRH patch (Drug)
Placebo
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: placebo clomiphene citrate (Drug)
Placebo
Placebo GnRH iontophoretic transdermal Lutrepatch with a high target delivery of pulsatile current (every 90 minutes) for 21 days and oral placebo clomiphene citrate for 5 days
干预措施: placebo GnRH patch (Drug)
结局指标
主要结局
Ovulation rate
时间窗: 30 days
次要结局
- Pregnancy rate(30 days)
- Incidence of Ovarian Hyperstimulation Syndrome (OHSS)(30 days)
- Incidence of skin irritation(30 days)