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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT05388656
Eligibility Criteria:
Inclusion Criteria:
* Healthy women 45 - 59 years of age
* In the early menopause transition (defined by variable menstrual cycle length that is 7+ days longer or shorter than usual)
* Increase in irritability since the onset of menstrual cycle changes
* Moderate to severe irritability symptoms, as defined by IDAS ill-temper scale score \>10
* Have experienced 1+ very stressful life event (e.g. divorce, death of family member) within the past 6 months
* Negative mammogram within the past two years
* BMI between 18 - 45 kg/m\^2
Exclusion Criteria:
* Use of psychotropic agents or hormonal preparations, or herbal supplements (other than multivitamins) believed to affect mood or menopausal symptoms
* History of psychosis, bipolar disorder, or substance dependence
* Active psychological symptoms severe enough to require treatment
* Current suicidal intent or recent history of suicide attempts (within past 10 years)
* Personal or family history of cancer indicative of more than average risk for breast, ovarian or endometrial cancers
* Personal history of any cardiovascular disease including coronary artery disease, arteriosclerosis, heart attack, stroke
* Personal history of thromboembolic disorders
* History of E2-dependent neoplasia
* History of gallbladder disease
* Recent history of migraine with aura
* Blood pressure classified as higher than stage 2 hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic)
* Liver dysfunction or disease
* Undiagnosed abnormal genital bleeding
* Type I diabetes
* Known sensitivities to the matrix patch system in Climara® or allergy to peanut oil used in Prometrium®
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
59 Years
Study:
NCT05388656
Study Brief:
Protocol Section:
NCT05388656