NCT06530459 The MUSE Study for Menopausal Arthralgia
| NCT ID | NCT06530459 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | National University Hospital, Singapore |
| Condition | Arthralgia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-08-01 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators plan to conduct a pilot 4-arm, randomized study comprising the following interventions: muscle strengthening exercises (MSE) alone, estrogen therapy (ET) alone, and a combination of MSE and ET, compared to usual care in women with menopausal arthralgia. The aim of this pilot study is to assess the feasibility, patient acceptability, and patient perspectives and logistics of delivering interventions, and practicability of outcome assessment tools in this 4-arm study over a 12-week period.
Eligibility Criteria
INCLUSION CRITERIA: 1. Patients with muscle stiffness and joint discomfort in various sites, including hands, knees, back, hips, and/or shoulders. Patients with pain in only one isolated joint would not be accepted. 2. Arthralgia symptoms with onset, or has become worse, over the perimenopausal or early postmenopausal period (within 5 years of the menopause). 3. Women should be at the menopause transition, less than or equal to 59 years old at the time of enrollment, or within 5 years of menopause whichever is earlier. . 4. Arthralgia for at least 3 months (pain lasting beyond normal injury healing period) 5. Community-dwelling and able to ambulate independently. EXCLUSION CRITERIA: 1. History of thrombo-embolic diseases, strokes, ischemic heart disease, dementia or psychiatric disorders, active liver disease or renal impairment, severe hyperlipidemia, gout, thyroid disease, systemic lupus erythematosus, rheumatoid arthritis, or other chronic inflammatory conditions. 2. Pregnancy 3. Non-adherence to national guidelines for breast cancer screening 4. High risk for breast cancer 5. Any joint surgery within the last 6 months 6. Severe obesity: BMI\>35 7. Migraine with aura 8. Poorly controlled diabetes 9. Use of any form of female hormone supplementation within the past 12 weeks. 10. High venous thromboembolism risk 11. Current cholecystitis, fibroids, or undiagnosed abnormal uterine bleeding. 12. Current smoker. 13. History of endometrial, ovarian, peritoneal, cervical, breast or endocrine-dependent cancers. 14. Receiving treatment for any form of cancer. 15. History of fragility bone fractures within the 2 years. 16. Any other cognitive, musculoskeletal, neurological, and cardiorespiratory condition affecting one's ability to participate in the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06530459 clinical trial?
This trial is open to female participants only, aged 30 Years or older, up to 59 Years, studying Arthralgia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06530459 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06530459 currently recruiting?
Yes, NCT06530459 is actively recruiting participants. Contact the research team at obgyel@nus.edu.sg for enrollment information.
Where is the NCT06530459 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06530459 clinical trial?
NCT06530459 is sponsored by National University Hospital, Singapore. The trial plans to enroll 100 participants.