A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 31
- 主要终点
- Menstrual Cycle Duration
研究概览
简要总结
This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.
详细描述
Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Oligo-/amenorrhea
- •At least one of the following during Screening:
- •Clinical signs of hyperandrogenism, where clinical hyperandrogenism may include hirsutism (defined as excessive terminal hair that appears in a male pattern), acne, or androgenic alopecia
- •Biochemical hyperandrogenism refers to an elevated serum androgen level (i.e., total, bioavailable or free testosterone level ≥ULN)
- •Polycystic ovarian morphology, defined as the presence of 12 or more follicles 2-9 mm in diameter and/or an increased ovarian volume >10 mL (without a cyst or dominant follicle) in either ovary
- •Body mass index (BMI) 22 to 45 kg/m2, inclusive
- •Must be willing to avoid use of all hair removal procedures and products during study participation
- •Must be willing to avoid all prescription treatments for acne and not increase the dose or frequency of their current non-prescription acne treatment regimen during study participation
- •Must be willing to avoid the use of all hair growth procedures and products during study participation
- •Permanently surgically sterilized (bilateral salpingectomy or tubal occlusion) >2 years or male partner(s) has had a vasectomy >2 years or must consent to use two permitted medically-acceptable methods of contraception throughout the study during any sexual intercourse with a male partner. Permitted medically-acceptable methods of birth control for this study are defined as use of a male condom plus one of the following: spermicide, diaphragm with spermicide, or an intrauterine device that does not contain steroid hormones.
排除标准
- •Menopausal or peri-menopausal, defined for this study as FSH (follicle stimulating hormone ) >10 IU/L
- •Irregular vaginal/menstrual bleeding caused by conditions other than PCOS (e.g., uterine polyps or submucosal uterine fibroids)
- •Abnormal Papanicolaou (Pap) test during Screening requiring follow-up sooner than 1 year after the test
- •Uncontrolled hypo- or hyperthyroidism
- •Post-hysterectomy or endometrial ablation
- •Post-oophorectomy (unilateral or bilateral) or other ovarian surgery
- •Medical history of type 1 or type 2 diabetes mellitus
研究组 & 干预措施
Placebo
Plain, round, biconvex, white film-coated tablets that appear identical to MLE4901 tablets
干预措施: Placebo (Drug)
MLE4901
Plain, round, biconvex, white film-coated tablets administered twice per day
干预措施: MLE4901 (Drug)
结局指标
主要结局
Menstrual Cycle Duration
时间窗: 28 Week double blind treatment period
Assessment of the number of days between menstrual cycles (i.e., days between the start of a menstrual period and the start of the next consecutive menstrual period) from baseline to end of 28 week double blind treatment period
次要结局
- Number of Menstrual Periods(28 Week double blind treatment period)