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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT06583408
Eligibility Criteria:
Inclusion Criteria:
* 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to:
* Estradiol: \< 50pg/mL
* LH: \< 10 IU/mL
* FSH: \< 10 IU
* Testosterone: 2 - 45 ng/dL
* Free Testosterone: 0.1 - 6.4 pg/mL
* FT4: 0.93 - 1.70 ng/dL
* Prolactin: \< 20 ng/mL
* AMH: \> 1 ng/mL
* Urine or serum human chorionic gonadotropin: Negative
* LH:FSH Ratio \<1
* No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back
* Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
* Premenopausal status determined by WISE criteria
* Able to give informed consent
* Able to read English
Exclusion Criteria:
* Parturition/lactating in the last 6-12 months
* Lack of consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06583408
Study Brief:
Protocol Section:
NCT06583408