Oral Contraceptive During Menopausal Transition

Not Applicable

• Conditions: Perimenopause
• Interventions: Drug: oral contraceptive; Drug: NSAID

• Registration Number: NCT01414530
• Lead Sponsor: Samsung Medical Center

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-06-28
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-09
• Last Update Posted: 2013-09-10
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral contraceptive	oral contraceptive	-
NSAID	NSAID	-

Primary Outcome Measures

Name	Time	Method
improvement in symptoms	Eight weeks	evaluated by fibromyalgia impact questionnaire and visual analogue scale

Secondary Outcome Measures

Name	Time	Method
quality of life	Eight weeks	evaluated by SF-12

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of