Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- improvement in symptoms
研究概览
简要总结
Muscle or joint pain is one of the most common symptoms during menopausal transition. As this could be severe enough to affect social and daily life and to reduce quality of life, attentions should be paid about this.
Although understanding of muscle or joint pain related to menopause is still insufficient, estrogen can play an important role. Previous studies have shown that estrogen protects cartilage in both animals and humans.
However, perimenopause is different from postmenopause, in the point that estrogen is still secreted with a great fluctuation.
Until now, no study has been performed to evaluate the effects of oral contraceptive on muscle or joint pain in women during menopausal transition. Moreover, since menopausal symptoms vary according to ethnicity and culture, a study in Korean population is necessary.
Therefore, this randomized controlled trial was designed to evaluate the effects of oral contraceptive on muscle or joint pain in women during menopausal transition, compared to NSAID (non-steroidal anti-inflammatory drug).
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
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Perimenopausal women aged 45 or more
- •Women who have multiple joint or muscle pain for at least 3 months (at least two sites out of upper and lower extremities or axial)
排除标准
- •Rheumatoid arthritis, ankylosing spondylitis, rheumatic polymyalgia, Inflammatory myopathy
- •pregnancy
- •History of hysterectomy or bilateral oophorectomy
- •Vasomotor symptoms
- •History of surgery of musculoskeletal system
- •History of cancer
- •Abnormalities of thyroid function
- •Focal neurologic deficit
- •Smoking within 1 year
- •Uncontrolled hypertension
- •Coronary heart disease
- •Diabetes mellitus
- •Active thromboembolism
- •Undiagnosed vaginal bleeding
- •Acute hepatic dysfunction
- •Gastrointestinal ulcer
- •Severe renal dysfunction
- •Hypersensitivity to drugs
- •Current hormone user or past users within 3 months
研究组 & 干预措施
oral contraceptive
干预措施: oral contraceptive (Drug)
NSAID
干预措施: NSAID (Drug)
结局指标
主要结局
improvement in symptoms
时间窗: Eight weeks
evaluated by fibromyalgia impact questionnaire and visual analogue scale
次要结局
- quality of life(Eight weeks)
研究者
Byung-Koo Yoon
Professor
Samsung Medical Center