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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral contraceptive | Experimental |
| |
| NSAID | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral contraceptive | Drug | ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| improvement in symptoms | evaluated by fibromyalgia impact questionnaire and visual analogue scale | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | evaluated by SF-12 | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byung-Koo Yoon, MD, PhD | Contact | 82-2-3410-3512 | bkyoon.yoon@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | Gangnam-gu | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| NSAID | Drug | ibuprofen 200mg/arginine 185mg twice per day for 8 weeks |
|
|
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D000893 | Anti-Inflammatory Agents |
| D018501 | Antirheumatic Agents |