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:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT06610305
Eligibility Criteria:
Inclusion Criteria:
* Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause).
* Self-reported regular menstrual cycles between 25 and 35 days.
* A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms.
* If the woman has children, she must be at least 1 year postpartum.
* English-speaking
Exclusion Criteria:
* Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again at the first visit of the second condition. Women will be instructed to use a barrier method of birth control during the study.
* Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women who were previously taking oral contraceptives or other hormonal medications must have one normal menstrual cycle (menstrual period) prior to enrollment in the study.
* BMI less than 18 or greater than 29.
* A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, pulmonary disease, migraine with aura, hypertension, Parkinson's disease, chronic pain, and thromboembolic events.
* A family history indicative of increased risk of breast cancer or thromboembolic disorders.
* Current cigarette smoking.
* A history of mania, psychosis, or substance use disorder.
* Any recent history (last 12 months) of active suicidal ideation, or suicide attempt within the last 5 years.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06610305
Study Brief:
Protocol Section:
NCT06610305