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 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT05629858
Eligibility Criteria:
4.1 Inclusion criteria:
* Diagnosed with PCOS based on the Rotterdam criteria in which two of three of the following criteria are present: (i) androgen excess skin manifestations (hirsutism, acne, and seborrhea) and/or hyperandrogenemia (total testosterone \>55 pg/ml, free testosterone \>9.4 pg/ml, androstenedione \>2.1 ng/ml or DHEA-S \>340 ug/dl); (ii) polycystic ovarian morphology on ultrasound (ovarian volume \>10 cc and /or antral follicle count 20 in at least one ovary); and (iii) chronic oligo-amenorrhea (intermenstrual intervals \>35 days or 7 periods/year)
* BMI between 25-50 kg/m2
* Age between 18-45 years
4.2 Exclusion criteria:
* Postmenopausal (absence of menses for \>2 y)
* Diagnosed type 1 diabetes or type 2 diabetes
* Previously diagnosed with a mood depressive disorder (by a doctor or psychologist)
* Have a history of eating disorders (anorexia, bulimia, or binge eating disorder)
* Are not weight stable for 3 months prior to the beginning of the study
* Are taking drugs that affect study outcomes, such as oral contraceptives, weight loss, insulin-sensitizing agents, androgen antagonists, anti-seizure, or antipsychotic medication (within 2 months of starting study)
* Are currently following a TRE protocol
* Are athletes or those engaging in \>1 hour of high-intensity training on more than 5 days/week
* Are active smokers (within 3 months of starting the study)
* Do not have a Wi-Fi connection at home (needed for zoom calls)
* Pregnant or trying to become pregnant
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT05629858
Study Brief:
Protocol Section:
NCT05629858