Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Serum LH level
研究概览
简要总结
The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.
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 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
0.0625 mg
Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.0625 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude
干预措施: Ganirelix (Drug)
0.025 mg
Test the efficacy of Ganirelix administered subcutaneously at single-dose regimen of 0.025 mg in 10 women with PCOS, in rectifying LH pulse frequency and LH amplitude.
干预措施: Ganirelix (Drug)
结局指标
主要结局
Serum LH level
时间窗: every 10 minutes for 8 hours
The degree of gonadotropin suppression will be determined by calculating the percent inhibition from the pre-antagonist period \[(mean PRE - nadir)/mean PRE\] x 100, where nadir hormone levels will be calculated using a moving average.
次要结局
- change in AMH levels(at 4 hours post-injection)
- Variation in androgen production(at 4 hours after injection)
- change in FSH levels(at 4 hours post-injection)
- Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve)(at the beginning and at the end of the 8 hours)
- change in estradiol levels(at 4 hours post-injection)
研究者
Pr Sophie CATTEAU JONARD
Scientific
Centre Hospitalier Universitaire De Lille