Perimenopause
Conditions
Brief summary
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).
Interventions
DRUGoral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
DRUGNSAID
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Stoke * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement in symptoms | Eight weeks | evaluated by fibromyalgia impact questionnaire and visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | Eight weeks | evaluated by SF-12 |
Countries
South Korea
Contacts
Primary ContactByung-Koo Yoon, MD, PhD
Outcome results
None listed