RECRUITING

The REgistry of Very Early Estrogen and AnovuLation

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Conditions

Hypothalamic Amenorrhea, FunctionalHypothalamic AmenorrheaFunctional Hypogonadotropic HypogonadismAnovulationEstrogen LossHypoestrogenemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The REgistry of Very Early Estrogen and AnovuLation

Quick Facts

Study Start:2024-07-01
Study Completion:2029-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06583408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. * Estradiol: \< 50pg/mL
  3. * LH: \< 10 IU/mL
  4. * FSH: \< 10 IU
  5. * Testosterone: 2 - 45 ng/dL
  6. * Free Testosterone: 0.1 - 6.4 pg/mL
  7. * FT4: 0.93 - 1.70 ng/dL
  8. * Prolactin: \< 20 ng/mL
  9. * AMH: \> 1 ng/mL
  10. * Urine or serum human chorionic gonadotropin: Negative
  11. * LH:FSH Ratio \<1
  12. * No signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back
  13. * Does not have a diagnosis for secondary amenorrhea, including prolactinoma, PCOS, premature ovarian insufficiency, pituitary surgery, infection, or infarction
  14. * Premenopausal status determined by WISE criteria
  15. * Able to give informed consent
  16. * Able to read English
  1. * Parturition/lactating in the last 6-12 months
  2. * Lack of consent

Contacts and Locations

Study Contact

Katie A. Cruz
CONTACT
507-284-7866
cruz.katie@mayo.edu
Chrisandra L Shufelt
CONTACT
904 953-7224
DLREVEAL@exchange.mayo.edu

Principal Investigator

Chrisandra Shufelt, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Jacksonville, Florida, 32224
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Chrisandra Shufelt, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-01
Study Completion Date2029-08-01

Study Record Updates

Study Start Date2024-07-01
Study Completion Date2029-08-01

Terms related to this study

Keywords Provided by Researchers

  • Anovulation
  • Estrogen Loss
  • Hypoestrogenemia

Additional Relevant MeSH Terms

  • Hypothalamic Amenorrhea, Functional
  • Hypothalamic Amenorrhea
  • Functional Hypogonadotropic Hypogonadism