Oral Contraceptive During Menopausal Transition

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Byung-Koo Yoon, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01414530
First received: June 28, 2011
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Samsung Medical Center:

Primary Outcome Measures:
  • improvement in symptoms [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    evaluated by fibromyalgia impact questionnaire and visual analogue scale


Secondary Outcome Measures:
  • quality of life [ Time Frame: Eight weeks ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Byung-Koo Yoon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01414530     History of Changes
Other Study ID Numbers: 2010-03-018
Study First Received: June 28, 2011
Last Updated: September 9, 2013
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014