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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT01607320
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 18 to 36
2. BMI \> 19 \& \< 40
3. PCOS diagnosis as evidenced by:
Oligo- and/or anovulation (\< 6 cycles per year) and one of the following:
* Clinical and/or biochemical signs of hyperandrogenism
* Polycystic ovaries and exclusion of other aetiologies (congenital adrenal hyperplasias, androgen-secreting tumors, Cushing's syndrome)
Exclusion Criteria:
1. Use of ovulation induction agents within the past 6 months
2. Positive pregnancy test before taking study medications
3. History or current thromboembolic disorder
4. Coronary artery disease such as heart attack or stroke
5. Tobacco use or history within the past 6 months
6. History of pelvic inflammatory disease and tubal factor infertility
7. Congenital adrenal hyperplasia
8. Diabetes Mellitus
* Any subject on Metformin must "wash out" for 30 days prior to screening
9. History of endometriosis
10. Known male factor infertility
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
36 Years
Study:
NCT01607320
Study Brief:
Protocol Section:
NCT01607320