Perimenopause | Oral Contraceptive During Menopausal Transition
Perimenopause research study
What is the primary objective of this study?
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).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:oral contraceptiveethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
Drug:NSAIDibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: April 2010
Primary Outcome: improvement in symptoms
Secondary Outcome: quality of life
Study sponsors, principal investigator, and references
Lead Sponsor: Samsung Medical Center