MedTrace Logo

Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

NCT07386223 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Hypothalamic Amenorrhea, Functional

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.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • FoU Centrum, Landstinget Sörmland

    collaborator OTHER_GOV

  • Karolinska Institutet

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-01-01
Completion
2028-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386223 on ClinicalTrials.gov