Registry for women with early estrogen loss due to hypothalamic amenorrhea
The REgistry of Very Early Estrogen and AnovuLation
Mayo Clinic · NCT06583408
This study is creating a registry to learn more about women who have early estrogen loss from hypothalamic amenorrhea, focusing on their health, lifestyle, and the diversity of this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100000 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Mayo Clinic (other) |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT06583408 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry of women experiencing early estrogen loss caused by Functional Hypothalamic Amenorrhea (FHA). It will collect data to understand the prevalence and racial and ethnic diversity of this condition. Participants will complete an automated dietary assessment and a questionnaire to provide insights into their health and lifestyle. The study focuses on women who have experienced three or more months of amenorrhea and meet specific hormonal criteria.
Who should consider this trial
Good fit: Ideal candidates are women with a diagnosis of functional hypothalamic amenorrhea who have experienced consecutive amenorrhea for three months or more.
Not a fit: Patients with secondary amenorrhea or those who have recently given birth or are lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of hypothalamic amenorrhea and lead to better management strategies for affected women.
How similar studies have performed: While this approach is observational and may not have direct precedents, similar studies on hormonal conditions have provided valuable insights into patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic — Jacksonville, Florida, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Chrisandra Shufelt, MD — Mayo Clinic
- Study coordinator: Chandler E. Palmer, MHA
- Email: palmer.chandler@mayo.edu
- Phone: 904-953-5438
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypothalamic Amenorrhea, Functional, Hypothalamic Amenorrhea, Functional Hypogonadotropic Hypogonadism, Anovulation, Estrogen Loss, Hypoestrogenemia