NCT00785356终止3 期
A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 7
- 主要终点
- The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
研究概览
简要总结
Subjects will be randomly assigned to one of 3 treatment groups and receive 325 mg (65 mg elemental iron) iron supplements twice daily.
详细描述
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
- •Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
- •Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
- •Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
排除标准
- •Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:
- •Six months or more (immediately prior to Screening Visit) without a menstrual period, or
- •Prior hysterectomy, or
- •Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
- •Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
- •Documented endometriosis or active pelvic inflammatory disease (PID);
- •Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
- •Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
- •Use of prohibited concomitant medications:
- •Depo-Provera use must cease ten months prior to first dose of study drug, or
- •GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
- •Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
研究组 & 干预措施
25 mg Proellex
Experimental
Proellex 25 mg
干预措施: Proellex 25 mg (Drug)
Proellex 50 mg
Experimental
Proellex 50 mg
干预措施: Proellex 50 mg (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Comparison Between the 50 mg Proellex® Dose Level and Placebo in the Change in Hemoglobin From Baseline to 3 Months.
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (7)
Loading locations...
相似试验
已完成
3 期
A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisNCT00152386UCB Pharma950
已完成
2 期
Safety Study of Anti-IgE Immunotherapy in Allergic PatientsAllergyNCT00439621Resistentia Pharmaceuticals AB42
终止
3 期
Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine FibroidsUterine FibroidsAnemiaNCT00702702Repros Therapeutics Inc.56
终止
3 期
A Study to Test the Efficacy and Safety of Padsevonil as Treatment of Focal-onset Seizures in Adult Subjects With Drug-resistant EpilepsyDrug-Resistant EpilepsyFocal-Onset SeizuresNCT03739840UCB Biopharma SRL232
终止
2 期
Efficacy and Safety of Lu AA34893 in Patients With Major Depressive DisorderMajor Depressive DisorderNCT00766870H. Lundbeck A/S35