Effects of a Kappa Agonist on Hot Flashes in Menopausal Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Hot Flashes
研究概览
简要总结
Studies suggest that kappa agonists (KA) and peripherally restricted kappa agonists (PRKAs) may affect thermoregulation. This pilot study has the aim to establish proof of concept regarding efficacy of an oral kappa agonist (KA) for the treatment of menopausal hot flashes.
详细描述
To establish proof of concept regarding efficacy of an oral kappa agonist (KA), Pentazocine/ Naloxone 50/0.5 mg, for the treatment of menopausal hot flashes.
To gather data in support of a future proposal to study the safety and efficacy of a PRKA, a type of KA, for amelioration of menopausal hot flashes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women 45-60 years of age; 12 months amenorrhea
- •Documentation of > 8 moderate to severe, daily hot flashes during one week of baseline monitoring using daily diaries
- •Availability of a family member or friend to drive participant home following clinic visits
排除标准
- •Use of hormonal prescription medication or supplements for vasomotor symptoms (VMS)
- •Use of narcotics
- •Use of SSRI (selective serotonin reuptake inhibitor)/SNRI (serotonin-norepinephrine reuptake inhibitors), gabapentin, MAOI (monoamine oxidase inhibitor), anti-epileptics, sedatives
- •History of polycystic ovarian syndrome or hirsutism
- •Current history of depression
- •Any chronic or acute medical illnesses including renal, hepatic, pulmonary diseases, or seizures
- •Substance abuse
- •Severe corn allergy
- •Known allergic reaction to pentazocine or naloxone
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Hysterectomy
- •Use of anticholinergic medications
- •Lactating or pregnant
研究组 & 干预措施
Placebo
Cornstarch, National Formulary
干预措施: Placebo (Other)
Standard Dose Kappa Agonist
Pentazocine/Naloxone 50/0.5 mg
干预措施: Standard Dose Kappa Agonist (Drug)
Half Dose Kappa Agonist
Pentazocine/Naloxone 25/0.25 mg
干预措施: Half Dose Kappa Agonist (Drug)
结局指标
主要结局
Hot Flashes
时间窗: 1-4 weeks
Objectively measured hot flash frequency by changes in skin conductance over 8 hours on 3 separate study visits 3-14 days apart.
次要结局
- Subjectively measured hot flashes(1-4 weeks)
- Change in Serum Leutinizing Hormone(1-4 weeks)
研究者
Susan Reed
Professor, Obstetrics & Gynecology
University of Washington