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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT03018366
Eligibility Criteria:
Inclusion Criteria:
For premenopausal Hypo E and normal control women, inclusions include:
* Premenopausal currently not on hormone therapy,
* English speaking (for the purposes of complete psychosocial assessment)
* able to give informed consent
* a gynecological age (age since menarche) \> 10 and \< 25 years, and chronological age \> 18 years
* Within 90-110% of ideal body weight as determined by the 1983 Metropolitan Height and weight table for women
* All participants with hypothalamic amenorrhea will be diagnosed based on exclusion of other etiologies for their amenorrhea, including pregnancy, thyroid dysfunction, hyperprolactinemia, premature ovarian insufficiency, and polycystic ovary disease
For recently menopausal women inclusions include:
* Follicle stimulating hormones (FSH) \>30 and 12 months of amenorrhea, within 3 years of final menstrual period with natural menopausal not on hormone therapy
* English speaking
* Able to give informed consent
* Within 90-110% of ideal body weight
Exclusion Criteria:
For premenopausal Hypo E and normal control women exclusions include:
* Smoking
* Hypertension
* Hyperlipidemia
* Diabetes
* Medications including psychotropic or illicit drugs, medical, neurological
* Ophthalmologic disease except acuity problems
* Major Axis I disorder other than depression
* Pregnancy in the last 12 months and/or lactating in the last 6 months
* Current use of hormone contraceptive or any estrogen or progestin therapy
For HypoE women, exclusion criteria include:
\- Allergy to adhesive or tape
For recently menopausal women exclusions also include:
* Previous or current use of hormone therapy, estrogen or progestin
* Surgical or chemotherapy induced menopause
* Premature ovarian failure
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03018366
Study Brief:
Protocol Section:
NCT03018366