The REgistry of Very Early Estrogen and AnovuLation

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The purpose of this study is to to build a registry of women with early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA) to understand the prevalence, racial and ethnic diversity of this condition.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
Mayo Clinic
RECRUITING
Jacksonville
Minnesota
Mayo Clinic
RECRUITING
Rochester
Contact Information
Primary
Katie A. Cruz
cruz.katie@mayo.edu
507-284-7866
Backup
Chrisandra L Shufelt
DLREVEAL@exchange.mayo.edu
904 953-7224
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 100000
Treatments
Women with > 3 months amenorrhea
Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov