drugset / Trial / NCT01414530

Oral Contraceptive During Menopausal Transition

NCT01414530

Unknown 52 enrolled Samsung Medical Center
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2010-04
Primary completion
2014-06
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibuprofen Small molecule 200 mg
Comparator L-arginine Small molecule 185 mg
Subject Levonorgestrel Small molecule 0.15 mg Oral
Subject ethinyl estradiol Small molecule 0.03 mg Oral

Indications