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 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT01178892
Eligibility Criteria:
Inclusion Criteria:
* Females aged 40-62 years.
* Menopausal, including:
* Women who have had a bi-lateral oophorectomy;
* Women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval of 60 or more days in the past 12 months;
* Women without a uterus and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL;
* Women who are using the Mirena IUD or who have had an endometrial ablation and who still have one or both ovaries, with FSH level greater than 20 mIU/mL and estradiol less than or equal to 50 pg/mL.
* Having bothersome hot flashes and/or night sweats.
* In general good health as determined by medical history, blood pressure, and heart rate:
* Absence of uncontrolled hypertension greater than 160/100;
* Resting heart rate less than 110 beats per minute;.
* No history of myocardial infarction, angina, or cerebrovascular events;.
* No history of liver, renal disease, or uncontrolled seizure disorder.
* Absence of uncontrolled metabolic disease (such as diabetes) and absence of current infectious disease (such as acute symptoms of mononucleosis) that would put staff and other participants at risk.
* Signed informed consent.
Exclusion Criteria:
* Use of hormone therapy or hormonal contraceptives (with the exception of the Mirena IUD) during the 2 months before enrollment. Vaginal postmenopausal estrogens allowed, with the exception of vaginal creams used more than 3 times a week.
* Use of any other therapy that is taken specifically for hot flashes, including prescription, over-the-counter, or herbal therapies, in the past month.
* Any current severe or unstable medical illness.
* Body mass index (BMI) of 37 or higher, based on measured height and weight.
* Severe uncorrected hearing or vision problems.
* Current, regular use of anti-coagulants 3 or more times per week, e.g. Coumadin, Heparin, Clopidogrel, aspirin at full dose (due to possible omega-3 supplement interaction).
* Drug or alcohol abuse in the past 1 year.
* Major severe depressive episode in the past 3 months.
* Diagnosis of psychosis or psychotic disorder.
* Pregnancy, intending pregnancy, or breastfeeding.
* Current participation in another drug trial or intervention study.
* Inability or unwillingness to complete the study procedures or interventions.
* Physical limitations that limit the ability to participate in yoga or exercise, for example:
* Limited mobility (paralyzed, cannot walk 2 blocks);
* Back problems (severe spine abnormality, sciatica, prior back surgery, spine fracture in the past 3 months);
* musculoskeletal problems that limit the ability to walk on a treadmill or ride a stationary bicycle;
* Presence of any absolute contraindications to exercise testing and training, as defined by the American College of Sports Medicine.
* Practiced or attended any of the following in the prior 3 months:
* Yoga, tai chi, qi gong, or meditation more than one time per week on average;
* Aerobic exercise (more than 30 minutes a day on at least 3 days a week);
* Inability to achieve 85% of heart rate reserve (HRR; the difference between maximum heart rate and resting heart rate) on graded exercise treadmill test.
* Severe allergy to soy (defined as life-threatening reaction to soy that would require medical intervention).
* Allergy or sensitivity to fish.
* Currently eating 4 or more servings of fish per week.
* Currently taking an omega-3 fish oil supplement more than twice per week in the past 4 weeks and unwilling to stop for 12 weeks. Interest women can stop all omega-3 supplements and reevaluate eligibility 4 weeks after stopping the omega-3 supplements.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
62 Years
Study:
NCT01178892
Study Brief:
Protocol Section:
NCT01178892