Registry for Hypothalamic Amenorrhea
(REVEAL Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to create a registry of women experiencing early estrogen loss due to Functional Hypothalamic Amenorrhea (FHA), a condition where menstruation stops for several months due to stress, weight loss, or exercise. The goal is to understand the prevalence of this condition and its variations among different racial and ethnic groups. Women who have not had a period for over three months and have been diagnosed with FHA, or have hormone levels consistent with FHA, are eligible to participate. This research can enhance understanding of the diversity and impact of FHA on women's health. As an unphased study, this trial allows participants to contribute to foundational research that could improve understanding and treatment of FHA.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to better understand functional hypothalamic amenorrhea (FHA), a condition where women experience an absence of menstruation due to stress, weight loss, or exercise. Unlike traditional treatments that might involve hormone therapy to regulate menstrual cycles, this study is focusing on gathering comprehensive data about the early stages of estrogen deficiency and anovulation. By closely examining women with over three months of amenorrhea, the trial hopes to uncover insights that could lead to more personalized and effective treatment strategies in the future. This could potentially pave the way for interventions that are more tailored to the underlying causes of FHA, rather than just addressing the symptoms.
Who Is on the Research Team?
Chrisandra Shufelt, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Registry Enrollment
Participants are enrolled in a registry to track the prevalence, underlying causes, risk factors, and prognosis of Functional Hypothalamic Amenorrhea (FHA).
Follow-up
Participants are monitored for long-term health outcomes and the impact of various treatment interventions through annual questionnaires.
What Are the Treatments Tested in This Trial?
Interventions
- Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
- REVEAL Questionnaire
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Women aged 18-40 years old with a diagnosis of functional hypothalamic amenorrhea, or lab results that are within the inclusion criteria.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
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