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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT03229057
Eligibility Criteria:
Inclusion Criteria:
1. Women ≥ 18 to ≤ 40 years of age (at the time of screening), with hyperandrogenic PCOS.
2. Subjects will be diagnosed with PCOS defined by the most recent Rotterdam criteria based on:
1. androgen excess (defined as an elevated serum T level or hirsutism, based on a Ferriman Gallwey score \> 8 (note: \> 2 for women of Asian descent)
AND either:
2. history of chronic anovulation (8 or fewer periods per year)
AND/OR
3. polycystic ovaries.
3. BMI ≥ 25 kg/m² to ≤ 48 kg/m² obtained at screening visit.
4. In good general health.
5. Willing to avoid pregnancy for the duration of the study.
Exclusion Criteria:
1. Current pregnancy or desire of pregnancy during course of study
2. Currently breastfeeding
3. Known 21 hydroxylase deficiency
4. Untreated thyroid disease (TSH \<0.45 mlU/mL and \> 4.5 mlU/mL)
5. Untreated hyperprolactinemia (2 Levels\>30 ng/ml at least one week apart)
6. Type 1 or type 2 Diabetes Mellitus (elevated fasting serum glucose \>126mg/dL on two occasions, poorly controlled diabetes (HgbA1C\>6.5%), currently receiving anti-diabetic agents, or currently receiving metformin for treatment of diabetes
7. Liver disease (AST/ALT\>2 times normal or a total bilirubin \>2.5 mg/dL)
8. Renal disease (BUN\>30 mg/dL or serum creatinine \>1.4 mg/dL)
9. Anemia (hemoglobin \<10 mg/dL)
10. History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident
11. Current history of alcohol abuse (\>14drinks/week)
12. Poorly controlled hypertension defined as average systolic blood pressure \>= 150 mm Hg or average diastolic \>=100 mm Hg obtained on three measurements obtained 5 minutes apart. If treated, average systolic blood pressure \>=140 mm Hg or average diastolic \>=90 mm Hg
13. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma
14. TG\>200mg/dl
15. Use of lipid lowering or weight loss agents (subjects may wash out from weight loss agents)
16. Current use of oral contraceptives, depo progestin, or hormonal implants
17. Participation in any study of an investigational drug or device or biological agent within 30 days
18. Suspected adrenal or ovarian tumor secreting androgens
19. Suspected Cushing's syndrome
20. Bariatric surgery procedure in the recent past (\<12 months)
21. Absolute contraindications to the use of hormonal contraceptives or metformin,
23\. Subjects who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03229057
Study Brief:
Protocol Section:
NCT03229057