NCT01190475已完成2 期
A Randomized, Double-blind, Double-dummy, Placebo-controlled Study of Oral BGS649 Monotherapy Assessing Safety and Tolerability in Patients With Moderate to Severe Endometriosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
研究概览
简要总结
This study will assess the safety and tolerability of BGS649 in women with moderate to severe endometriosis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women with documented moderate to severe endometriosis. Occurrence of three sequential menstrual cycles of 24-35 days duration prior to enrollment.
- •Laparoscopically proven diagnosis of moderate to severe endometriosis (diagnosed within the past 10 years before screening).
- •Patients not planning to become pregnant within one year after the screening visit and willing to use two effective methods of non-hormonal, barrier birth control for the duration of the study or who are surgically sterile.
- •Patients must have a score of at least 4 on the numerical rating scale (NRS) for one of the following three pain measurements: pelvic pain, menstrual pain and dyspareunia
排除标准
- •Estrogen replacement therapy using either prescription medications or estrogen-containing OTC nutritional/herbal supplements such as soy extracts or topical estrogens.
- •Aromatase inhibitor therapy (includes Femara (letrozole), Aromasin (exemestane) or Arimidex (anastrozole) within the past 12 months.
- •Oral bisphosphonate therapy (i.e. Fosamax (alendronate)) within the past 6 months or intravenous bisphosphonate (i.e., Reclast, pamidronate) < 15 months from screening.
- •Systemic glucocorticoid therapy within the past 4 weeks.
- •Contra-indications to oral contraceptive use.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BGS649 high dose
Experimental
1 BGS649 1.0mg capsule with three 0.1 mg placebo capsules.
干预措施: Active treatment with a high dose of BGS649 (Drug)
BGS649 low dose
Experimental
1 BGS649 1.0 mg placebo capsule and 3 BGS649 0.1 mg capsules
干预措施: Active treatment with a low dose of BGS649 (Drug)
Placebo to BGS649
Placebo Comparator
1 matching placebo 1.0mg matching and three matching 0.1 mg placebo capsules
干预措施: Placebo treatment to blind study (Drug)
结局指标
主要结局
Proportion of Patients Who Develop 2 or More Follicles With Diameter 16 mm or Larger
时间窗: 8 months
Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger.
次要结局
- Pharmacokinetic Profile of BGS649 as Described by Cmax(8 hours)
- Pharmacokinetic Profille of BGS649 as Described by AUC0-672h(8 hours)
- Pharmacokinetic Profile of BGS649 as Described by Tmax(8 hours)
研究者
研究点 (1)
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