A Phase 1, Open-Label Study of the Effects of Elagolix on Ovarian Activity, Ovulation and Ovarian Reserve in Premenopausal Females
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 22
- 主要终点
- Ovulation Classification
研究概览
简要总结
This is an open-label Phase 1 study in healthy premenopausal females evaluating the effects of different dosing regimens of elagolix on ovarian activity, ovulation, and ovarian reserve and to assess the effect of elagolix on selected endocrine/hormone levels.
详细描述
This is an open-label, multiple-dose, Phase 1 study in premenopausal subjects aged 18 years to 40 years, with a history of regular menstrual cycles (24 to 32 days long) and no evidence of significant gynecological disorders. The objective of the study is to determine the effects of different dosing regimens of elagolix on ovulation, ovarian activity, and ovarian reserve. The study consists of 3 periods: a Screening Period of up to 50 days prior to the first dose, a Treatment Period of 3 months duration (Cycles 1-3), and a Follow-up Period of up to 60 days. During the Screening and Treatment menstrual cycles, serial transvaginal ultrasounds and determination of serum levels of luteinizing hormone, follicle-stimulating hormone, estradiol, progesterone, and inhibin B will be performed three times weekly. Subjects will maintain a daily diary of uterine bleeding. Pregnancy testing will be performed frequently throughout the study. Subjects will be required to use nonhormonal dual contraception consistently during the study, and will be counseled on appropriate and effective forms of birth control to promote pregnancy prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Premenopausal female, between 18 and 40 years of age, inclusive - History of regular menstrual cycles - Endocrine and ultrasonographic evidence of ovulation and normal ovulatory cycle during the screening period - Follicle-stimulating hormone level of <35 mIU/mL - Agrees to use required birth control methods during the entire length of participation in the study
排除标准
- •Screening ultrasound results show a clinically significant gynecological disorder - Surgical history of hysterectomy without oophorectomy, unilateral or bilateral oophorectomy, removal of ovarian cysts - Less than 6 months postpartum or post-lactation at the start of study drug dosing - Pregnant or breast feeding or is planning a pregnancy within the next 12 months - Testosterone concentration >120 ng/dL at screening
研究组 & 干预措施
Elagolix Dose Regimen 1
Elagolix Dose regimen 1 for 84 days
干预措施: elagolix (Drug)
Elagolix Dose Regimen 2
Elagolix Dose Regimen 2 for 84 days
干预措施: elagolix (Drug)
Elagolix Dose Regimen 3
Elagolix Dose Regimen 3 for 84 days
干预措施: elagolix (Drug)
Elagolix Dose Regimen 4
Elagolix Dose Regimen 4 for 84 days
Additional Dose Regimens may be added and will be administered for 84 days.
干预措施: elagolix (Drug)
Elagolix Dose Regimen 5
Elagolix Dose Regimen 5 for 84 days
干预措施: elagolix (Drug)
Elagolix Dose Regimen 6
Elagolix Dose Regimen 6 for 84 days
干预措施: elagolix (Drug)
Elagolix Dose Regimen 7
Elagolix Dose Regimen 7 for 84 days
干预措施: elagolix (Drug)
结局指标
主要结局
Ovulation Classification
时间窗: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
Presence or absence of ovulation
Ovarian Activity
时间窗: During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.
As measured by the Hoogland and Skouby 6-point ovarian activity grading system
次要结局
- Endocrine Parameters(During the 16 week study period (4 week screening period and 12 week treatment period) for up to month 3)
- Ovarian Reserve(During the baseline menstrual cycle and monthly during the treatment cycles 1, 2, and 3 for up to month 3.)
- Adverse events(All adverse events occurring through the Final Visit will be reported)
- Clinical Laboratory Tests(Change from baseline to Cycles 1, 2, and 3 or Final Visit)
- 12-lead Electrocardiogram(Change from baseline to Week 4 and Final Visit)
- Vital Signs(Change from baseline to Cycles 1, 2, and 3 or Final Visit)