Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-24 @ 2:23 PM
NCT ID:
NCT06530459
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.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
30 Years
Maximum Age:
59 Years
Study:
NCT06530459
Study Brief:
Protocol Section:
NCT06530459