Oral Contraceptive During Menopausal Transition
Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition
1 other identifier
interventional
52
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedSeptember 10, 2013
September 1, 2013
4.2 years
June 28, 2011
September 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
improvement in symptoms
evaluated by fibromyalgia impact questionnaire and visual analogue scale
Eight weeks
Secondary Outcomes (1)
quality of life
Eight weeks
Study Arms (2)
oral contraceptive
EXPERIMENTALNSAID
ACTIVE COMPARATORInterventions
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gangnam-gu, 135-710, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 28, 2011
First Posted
August 11, 2011
Study Start
April 1, 2010
Primary Completion
June 1, 2014
Last Updated
September 10, 2013
Record last verified: 2013-09