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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT05340634
Eligibility Criteria:
Inclusion Criteria:
1. Women newly diagnosed with PCOS with at least 2 of the following symptoms:
* Oligo/Anovulation \< 21 or \> 35 days \> 90 days (any cycle) \< 8 periods / year
* Hyperandrogenism (clinical symptoms or laboratory results)
* Polycystic ovary morphology (NHMRC guideline): In any ovary:
20 follicles\* and/or ovarian volume greater than or equal to 10ml and no corpus luteum, cysts or dominant follicles
\*number of follicles per ovary measuring 2-9 mm
2. \> 18 years old
3. Overweight defined as BMI\>25
4. Normal prolactin levels
5. Women with altered coagulation factors or a personal history of thromboembolism for whom OAC is contraindicated (they will be included in the control group without randomization)
6. Written inform consent
Exclusion Criteria:
1. Diabetic women
2. Adrenal enzyme deficiency and/or other endocrine disease
3. Pregnant or lactating women.
4. Women under treatment with SNRIs (serotonin reuptake inhibitors)
5. Other serious illness
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05340634
Study Brief:
Protocol Section:
NCT05340634