Oral Contraceptive During Menopausal Transition
Recruitment status was: Recruiting
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition|
- improvement in symptoms [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]evaluated by fibromyalgia impact questionnaire and visual analogue scale
- quality of life [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]evaluated by SF-12
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Experimental: oral contraceptive||
Drug: oral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
Other Name: Minivora
|Active Comparator: NSAID||
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Other Name: Carol-F
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414530
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Gangnam-gu, Korea, Republic of, 135-710|