Oral Contraceptive During Menopausal Transition

Samsung Medical Center

Status: Unknown

Conditions: Perimenopause

Treatments: Drug: oral contraceptive; Drug: NSAID

Study type: Interventional

Funder types: Other

Identifiers

NCT01414530

2010-03-018

Details and patient eligibility

About

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).

Enrollment: 52 estimated patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

oral contraceptive

Experimental group

Treatment:

Drug: oral contraceptive

NSAID

Active Comparator group

Treatment:

Drug: NSAID