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 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT03436992
Eligibility Criteria:
Inclusion Criteria:
* Both men and premenopausal
* Normal menstrual cycle interval of 25-35 days for at least 3 previous cycles
* All races
* Clinical diagnosis of insulin-dependent type 1 diabetes (patients only)
Exclusion Criteria:
* Clinical diagnosis of hepatic, cardiovascular, or renal disease
* Uncontrolled Diabetes (HbA1c\>9%)
* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
* Proteinuria
* Uncontrolled Hypertension (\>140/90 mmHg on therapy)
* Hormonal use of birth control (past 3 months)
* Pregnancy
* Oligomenorrhea
* Direct vasoactive medications (i.e. nitrates)
* Anti-estrogens (i.e. SERMs)
* Plycystic ovarian syndrome (defined by NIH guidelines-hyperandrogenic anovulation)
* Undetectable Anti-Mullerian Hormone (AMH) following screening
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT03436992
Study Brief:
Protocol Section:
NCT03436992