Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorKarolinska Institutet

About this trial

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.

Eligibility criteria

Qualifiers

female

aged 18-42 years

fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism)

basic proficiency in Swedish

Disqualifiers

Lack of proficiency in language

evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).

Trial design

Treatments tested in this trial

  • Psychoeducaction or treatment as usual
  • Treatment as usual (TAU)

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator

FoU Centrum, Landstinget Sörmland

Collaborator