Oral Contraceptive During Menopausal Transition
|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.|
|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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: oral contraceptive||
Drug: oral contraceptive
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
Other Name: Minivora
|Active Comparator: NSAID||
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
Other Name: Carol-F
- improvement in symptoms [ Time Frame: Eight weeks ]evaluated by fibromyalgia impact questionnaire and visual analogue scale
- quality of life [ Time Frame: Eight weeks ]evaluated by SF-12
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, PhDfirstname.lastname@example.org|
|Korea, Republic of|
|Samsung Medical Center||Recruiting|
|Seoul, Gangnam-gu, Korea, Republic of, 135-710|
|Contact: Byung-Koo Yoon 82-2-3410-3512|