PerimenopauseNCT01414530
Oral Contraceptive During Menopausal Transition
A study testing oral contraceptive and NSAID in people with Perimenopause, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopause
- What is being tested?
- oral contraceptive and NSAID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Gangnam-gu, 135-710
Byung-Koo Yoon, 82-2-3410-3512
About this study
Official title: Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition
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.
Read more
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).
- Conditions
- Perimenopause
- Being tested
- oral contraceptive, NSAID
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral contraceptiveDrug
Also called Minivora
ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
NSAIDDrug
Also called Carol-F
ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| oral contraceptive | Experimental | Not described Receives: Drug: oral contraceptive |
| NSAID | Active comparator | Not described Receives: Drug: NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in symptoms
evaluated by fibromyalgia impact questionnaire and visual analogue scale
Measured: Eight weeks
Secondary outcomes (1)
quality of life
evaluated by SF-12
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startApr 2010
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PerimenopauseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung-Koo Yoon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01414530
- Sponsor's protocol ID
- 2010-03-018
- Status last verified
- Sep 2013
- First submitted
- 28 Jun 2011
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Contraceptive on Muscle or Joint Ache in Women During Menopausal Transition
- ClinicalTrials.gov ID
- NCT01414530
- Acronym / sponsor ID
- 2010-03-018
- Conditions
- Perimenopause
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2014 (estimated)
- First posted
- 11 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral contraceptive | Experimental | Drug: oral contraceptive |
| NSAID | Active comparator | Drug: NSAID |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (20 listed)
- Rheumatoid arthritis, ankylosing spondylitis, rheumatic polymyalgia, Inflammatory myopathy
- pregnancy
- History of hysterectomy or bilateral oophorectomy
- Vasomotor symptoms
- History of surgery of musculoskeletal system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral contraceptiveAlso: Minivoraethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks | Drug | oral contraceptive |
| NSAIDAlso: Carol-Fibuprofen 200mg/arginine 185mg twice per day for 8 weeks | Drug | NSAID |
Primary outcome
improvement in symptoms
Time frame: Eight weeks
evaluated by fibromyalgia impact questionnaire and visual analogue scale
1 secondary outcome
quality of life
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
Related trials for Perimenopause
Not yet recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Recruiting
Hemodynamics After Resistance Training
Perimenopause
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Active, not recruiting
Relaxation Techniques and Pilates for Menopause Symptoms
Women Over 40 Years of Age in the Perimenopausal or Menopausal Stage, Presenting With Associated Symptoms
Enrolling by invitation
Transcutaneous Auricular Neurostimulation (tAN) for Premenstrual Dysphoric Disorder (PMDD) and Perimenopause
Perimenopause, PMDD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral contraceptive and NSAID in people with Perimenopause, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung-Koo Yoon, MD, PhD (82-2-3410-3512, bkyoon.yoon@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in symptoms (time frame: Eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.