NCT02937766终止3 期
A Phase III, Single-Center, Open-labeled, Randomized Controlled Study Assessing Injection Pain of Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subcutaneous Auto-injector vs Intramuscular Injection Via Needle and Syringe in Healthy Post-menopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison of Average Pain Intensity
研究概览
简要总结
To demonstrate that Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) delivered subcutaneously via auto-injector is associated with less pain as compared to intramuscular injections of Makena®
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
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female subjects aged 50 to 75 years of age, inclusive, at Screening Visit.
- •Follicle stimulating hormone (FSH) levels greater than 40 mIU/mL.
- •Naturally or surgically postmenopausal with or without an intact uterus.
排除标准
- •Have history of or positive test results for HIV or hepatitis B or C.
- •A significant history or current evidence of chronic infectious disease, organ dysfunction especially cardiovascular, renal, or hepatic disorders or other medical condition.
- •Receiving or have received chronic opioid therapy within 12 months.
- •Unwilling to stop taking/using:
- •pain medication.
- •topical analgesic or anti-inflammatory treatment. Topical analgesics must be washed out by at least 72 hours in the areas to be treated before randomization.
- •History of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) or prescription/illicit drug abuse in the last 12 months.
- •Currently taking any estrogen/progesterone hormone replacement therapy (HRT).
- •History of allergy or sensitivity to hydroxyprogesterone caproate, castor oil or any of the constituents of the study medications or history of any drug hypersensitivity or intolerance.
- •Poorly controlled diabetes (Hgb A1C >8).
- •Current or history of thrombosis or thromboembolic disorders.
- •Known or suspected breast cancer, other hormone-sensitive cancer or tumor, or history of these conditions within the last 5 years.
- •Any current or recent (within previous 12 months) vaginal bleeding.
- •Uncontrolled hypertension.
- •A chronic pain condition (i.e. chronic back pain) that may confound the assessments of injection pain.
研究组 & 干预措施
Treatment A
Experimental
Subcutaneous (SQ) injection using an autoinjector weekly over 4 weeks (4 injections)
干预措施: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (Drug)
Treatment B
Active Comparator
Intramuscular injection (IM) using syringe and needle weekly over 4 weeks (4 injections)
干预措施: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (Drug)
结局指标
主要结局
Comparison of Average Pain Intensity
时间窗: 4 weeks
Comparison of average pain intensity associated with the administration of Makena® via subcutaneous autoinjector versus intramuscular injection (averaged over 4 visits). Score on a scale: 0 (No Pain) up to 10 (Worst Pain Imaginable)
次要结局
- Clinician Assessment of Ease of Drug Preparation(4 weeks)
- Clinician Assessment of Ease of Injection Technique(4 weeks)
研究者
研究点 (1)
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