Oral Contraceptive During Menopausal Transition

Perimenopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01414530
• Other study ID #: 2010-03-018
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2011
• Last updated: September 9, 2013
• Start date: April 2010

Study information

• Verified date: September 2013
• Source: Samsung Medical Center
• Contact: Byung-Koo Yoon, MD, PhD
• Phone: 82-2-3410-3512
• Email: bkyoon.yoon[@]samsung.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perimenopause

Intervention

Drug:
• oral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
• NSAID
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Gangnam-gu

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in symptoms	evaluated by fibromyalgia impact questionnaire and visual analogue scale	Eight weeks	No
Secondary	quality of life	evaluated by SF-12	Eight weeks	No