NCT01862861已完成不适用
Relieving Vasomotor Symptoms Effectively With Bioidentical Hormone Replacement Therapy: The REVERT Study
Medimix Specialty Pharmacy, LLC1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2012年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.
研究概览
简要总结
Bioidentical Hormone Replacement Therapy (BHRT) to assess a change in the number of various menopausal symptoms such as hot flashes and night sweats in surgically or naturally induced peri or post-menopausal women.
详细描述
Participants will be receiving a customized bioidentical hormone regimen which may include a combination of estrogens, progesterone, and testosterone.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must be women who are in surgically or naturally induced menopause or perimenopause, as determined by their physician.
- •Participants must be starting a new regimen of bioidentical hormone replacement therapy.
- •Participants must be expected to receive therapy for at least 12 weeks.
- •Participants must be between 30 and 65 years of age.
- •Participants must be able to provide sound written informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf.
排除标准
- •Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
- •Participants must not be pregnant or breastfeeding women.
- •Participants must not be managed outside the Medimix Specialty Pharmacy system with regard to their bioidentical hormone replacement therapy.
- •Participants must not be using another bioidentical hormone at the time of enrollment.
结局指标
主要结局
To evaluate the efficacy of bioidentical hormone replacement therapy in decreasing the severity of vasomotor symptoms.
时间窗: 12 Week Study
The reduction of severity of vasomotor symptoms will be evaluated by utilizing the Menopause Rating Scale (MRS) from baseline to the end of study at 12 weeks.
次要结局
- To evaluate health-related quality of life (HrQol)(12 Weeks)
研究者
研究点 (1)
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