Registry for women with early estrogen loss due to hypothalamic amenorrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Centre Hospitalier Universitaire Vaudois · Lausanne, Canton of Vaud · NCT01601171

• Feasibility of a 10-week self-guided digital program for functional hypothalamic amenorrhea

  This pilot test checks whether a 10-week, self-guided web program for FHA is doable and acceptable for women, to pave the way for a larger trial.

  Recruiting at 2 sites Karolinska Institutet · Stockholm, Stockholm County and 1 other locations · NCT07589868

• Combining Chinese and Western medicine to restore menstrual cycles in hypothalamic amenorrhea

  This program will try a two-step approach—Western medicine to quickly restore menstrual bleeding and traditional Chinese medicine to support long-term hormonal balance—for women with functional hypothalamic amenorrhea.

  Recruiting Phase 4 Peking Union Medical College Hospital · Beijing · NCT07580950

• Mibavademab for adult women with functional hypothalamic amenorrhea

  This trial tests whether the experimental drug mibavademab helps adult women with functional hypothalamic amenorrhea make the hormones needed to resume ovulation and menstrual cycles.

  Recruiting at 10 sites Phase 2 Regeneron Pharmaceuticals · Phoenix, Arizona and 10 other locations · NCT07235917

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.