Oral Contraceptive During Menopausal Transition

Study Overview
=================
Brief 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).

Official Title
-----------------
Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition

Conditions
-----------------
Perimenopause

Intervention / Treatment
-----------------
* Drug: oral contraceptive
* Drug: NSAID


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oral contraceptive<br> | Drug: oral contraceptive<br>* ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks<br>* Other names: Minivora;|
| Active Comparator: NSAID<br> | Drug: NSAID<br>* ibuprofen 200mg/arginine 185mg twice per day for 8 weeks<br>* Other names: Carol-F;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement in symptoms | evaluated by fibromyalgia impact questionnaire and visual analogue scale | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | evaluated by SF-12 | Eight weeks |