Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Pregnancy
研究概览
简要总结
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).
详细描述
Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 36 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 36
- •BMI > 19 & < 40
- •PCOS diagnosis as evidenced by:
- •Oligo- and/or anovulation (< 6 cycles per year) and one of the following:
- •Clinical and/or biochemical signs of hyperandrogenism
- •Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)
排除标准
- •Use of ovulation induction agents within the past 6 months
- •Positive pregnancy test before taking study medications
- •History or current thromboembolic disorder
- •Coronary artery disease such as heart attack or stroke
- •Tobacco use or history within the past 6 months
- •History of pelvic inflammatory disease and tubal factor infertility
- •Congenital adrenal hyperplasia
- •Diabetes Mellitus
- •Any subject on Metformin must "wash out" for 30 days prior to screening
- •History of endometriosis
- •Known male factor infertility
研究组 & 干预措施
Raloxifene
3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7
干预措施: Raloxifene (Drug)
Clomiphene
3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
干预措施: Clomiphene (Drug)
结局指标
主要结局
Pregnancy
时间窗: 4 months
Time frame will vary depending on how many treatment cycles it takes to get pregnant. If no pregnancy occurs, study participation will likely be about 4 months.
次要结局
- Ovulation(Cycle day 22-24)
研究者
Bruce Lessey
MD, PhD. and Professor of Clinical Obstetrics & Gynecology, Dept of OB/GYN
Prisma Health-Upstate