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.
female
aged 18-42 years
fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism)
basic proficiency in Swedish
Lack of proficiency in language
evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).
Parallel
Psychoeducaction or treatment as usual
Behavioral10 week psychoeducaction or treatment as usual
Treatment as usual (TAU)
Other interventionStandard FHA management provided in routine clinical care.
Number of participants with return of spontaneous menstrual bleeding within 9 months
Restoration of menstruation is defined as a spontaneous menstrual bleed observed reported by the participants. Hormonal assessment will occur on cycle day 21 of the next menstrual cycle following intervention. The outcome will be reported as the number and proportion of participants who experience menstrual restoration.
Change in serum FSH, LH, and estradiol
For participants who have not experienced menstruation during follow-up serum FSH, LH, and estradiol levels will be measured to evaluate hormonal improvement. Changes from baseline will be reported as mean ± SD and as the proportion of participants showing increase in estradiol consistent with improved ovarian function.
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Karolinska Institutet
Lead sponsor
Karolinska University Hospital
Collaborator
FoU Centrum, Landstinget Sörmland
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
