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NOT YET RECRUITING
NCT07386223
NA

Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

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.

Official title: HEAL-FHA: Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

Key Details

Gender

FEMALE

Age Range

18 Years - 42 Years

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-02-01

Completion Date

2028-12-31

Last Updated

2026-02-04

Healthy Volunteers

No

Interventions

BEHAVIORAL

Psychoeducaction or treatment as usual

10 week psychoeducaction or treatment as usual

OTHER

Treatment as usual (TAU)

Standard FHA management provided in routine clinical care.

Locations (1)

Kvinnohälsan Karolinska Universitetssjukhuset

Stockholm, Sweden