Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2010-04-30
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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oral contraceptive
oral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
NSAID
NSAID
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Interventions
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oral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
NSAID
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
60 Years
FEMALE
Yes
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Byung-Koo Yoon
Professor
Locations
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Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Byung-Koo Yoon
Role: primary
Other Identifiers
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2010-03-018
Identifier Type: -
Identifier Source: org_study_id