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Oral Contraceptive During Menopausal Transition

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ClinicalTrials.gov Identifier: NCT01414530
Recruitment Status : Unknown
Verified September 2013 by Byung-Koo Yoon, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : August 11, 2011
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Byung-Koo Yoon, 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).


Condition or disease Intervention/treatment Phase
Perimenopause Drug: oral contraceptive Drug: NSAID Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition
Study Start Date : April 2010
Estimated Primary Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause
U.S. FDA Resources

Arm Intervention/treatment
Experimental: oral contraceptive Drug: oral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
Other Name: Minivora
Active Comparator: NSAID Drug: NSAID
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Other Name: Carol-F



Primary Outcome Measures :
  1. improvement in symptoms [ Time Frame: Eight weeks ]
    evaluated by fibromyalgia impact questionnaire and visual analogue scale


Secondary Outcome Measures :
  1. quality of life [ Time Frame: Eight weeks ]
    evaluated by SF-12



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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414530


Contacts
Contact: Byung-Koo Yoon, MD, PhD 82-2-3410-3512 bkyoon.yoon@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Gangnam-gu, Korea, Republic of, 135-710
Contact: Byung-Koo Yoon    82-2-3410-3512      
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Byung-Koo Yoon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01414530     History of Changes
Other Study ID Numbers: 2010-03-018
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female