Not Yet RecruitingNot Applicable

Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

Sweden70 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 42 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria * female * aged 18-42 years * fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism) * basic proficiency in Swedish * access to a computer. Exclusion Criteria: * Lack of proficiency in language * evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with return of spontaneous menstrual bleeding within 9 months

Timeframe: Restoration of menstruation after 9 months of follow-up

Change in serum FSH, LH, and estradiol

Timeframe: 12 months

Trial details

NCT IDNCT07386223

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Hedvig Engberg, MD PhD

+46 08 123 795 02 hedvig.engberg@ki.se

View on ClinicalTrials.gov More Hypothalamic Amenorrhea, Functional trials