Clinical Trial

Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

Study acronym: HEAL-FHA
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn whether a 10-week psychoeducational health and lifestyle intervention can help women with Functional Hypothalamic Amenorrhea (FHA) restore their endocrine balance and menstrual cycles. The main questions the study aims to answer are: Does the intervention lead to the return of regular menstrual bleeding? Does it improve hormonal markers associated with FHA recovery? To answer these questions, researchers will compare the 10-week psychoeducational intervention with treatment as usual (TAU). This comparison will help determine whether the structured program leads to faster or more reliable recovery of menstrual and endocrine function than the care women typically receive today. Participants will: Take part in a 10-week psychoeducational program focusing on health behaviors important for FHA recovery (intervention group) or receive treatment as usual (comparison group) Complete questionnaires and health assessments Provide blood samples to measure hormone levels Take part in a gynecological exam to monitor ovary activity and endometrial thickness Be followed for 9 months after the program to track progress This study builds on a previous feasibility study and will help determine whether the intervention is effective and should be used more widely to support women with FHA.
Trial Details
NCT Number NCT07386223
Lead Sponsor Karolinska Institutet
Collaborators: Karolinska University Hospital, FoU Centrum, Landstinget Sörmland
Conditions Hypothalamic Amenorrhea, Functional
Enrollment 70 participants
Start Date 2026-02-01
Primary Completion 2028-01-01 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-04