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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT05465135
Eligibility Criteria:
Inclusion Criteria:
* BMI 23-30kg/M2
* No plan for pregnancy in the coming 6 months
* Newly diagnosed PCOS, or PCOS without any medication for the past three months.
* Patients should meet all the three following criteria:
1. Oligomenorrhea or amenorrhea: Oligomenorrhea is defined as more than 35 days between menstrual periods and less than 8 menstrual bleedings in the past year; amenorrhea is defined as more than 90 days between two menstrual bleedings.
2. Polycystic ovaries: ≥12 follicles in both ovaries (diameter\<10mm), confirmed by ultrasound.
3. Elevated androgen levels: testosterone\>1.67 nmol/L.
Exclusion Criteria:
* Previously treated with steroids or other medications for PCOS in the past 3 months.
* Patients with other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc.
* Pregnancy.
* Patients with other serious diseases affecting heart, liver, kidney, or other major organs.
* Patients with any type of cancer.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
16 Years
Maximum Age:
35 Years
Study:
NCT05465135
Study Brief:
Protocol Section:
NCT05465135