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Oral Contraceptive During Menopausal Transition

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Byung-Koo Yoon, Samsung Medical Center.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: August 11, 2011
Last Update Posted: September 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Byung-Koo Yoon, Samsung Medical Center

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 Intervention
Perimenopause Drug: oral contraceptive Drug: NSAID

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Byung-Koo Yoon, Samsung Medical Center:

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

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

Estimated Enrollment: 52
Study Start Date: April 2010
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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

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
  Contacts and Locations
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

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

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
  More Information

Responsible Party: Byung-Koo Yoon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01414530     History of Changes
Other Study ID Numbers: 2010-03-018
First Submitted: June 28, 2011
First Posted: August 11, 2011
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