Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

NCT07386223 | Not Yet Recruiting

• 1 other identifier: 2023-05586-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

psychoeduction; lifestyle change; menstrual restoration; amenorrhea

Outcome Measures

Primary Outcomes (2)

• 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.

  Restoration of menstruation after 9 months of follow-up

• 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.

  12 months

Study Arms (2)

Psychoeducational Intervention

EXPERIMENTAL

Participants in this arm will take part in a 10-week psychoeducational health and lifestyle program designed to support behavioural change related to recovery from Functional Hypothalamic Amenorrhea (FHA). The intervention includes weekly modules focusing on nutrition, exercise behaviours, stress management, and recovery-promoting habits, delivered with evidence-based educational content and practical exercises. Participants will also complete questionnaires and provide blood samples at scheduled timepoints and will be followed for 9 months after the intervention.

Behavioral: Psychoeducaction or treatment as usual

Treatment as Usual (TAU)

ACTIVE COMPARATOR

Participants in this arm will receive treatment as usual for Functional Hypothalamic Amenorrhea, which may include general clinical advice, routine follow-up, and standard information provided by healthcare services. No structured psychoeducational program will be offered. Participants will complete questionnaires and provide blood samples at the same timepoints as the intervention group.

Other: Treatment as usual (TAU)

Interventions

Psychoeducaction or treatment as usual BEHAVIORAL

10 week psychoeducaction or treatment as usual

Psychoeducational Intervention

Treatment as usual (TAU) OTHER

Standard FHA management provided in routine clinical care.

Also known as: Standard FHA management provided in routine clinical care.

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female
• aged 18-42 years
• fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism)
• basic proficiency in Swedish
• access to a computer.

You may not qualify if:

• Lack of proficiency in language
• evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• FoU Centrum, Landstinget Sörmland: collaborator

Study Sites (1)

Kvinnohälsan Karolinska Universitetssjukhuset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Amenorrhea

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hedvig Engberg, MD PhD

CONTACT

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

Anna Strandqvist, PhD

CONTACT

+46 08 123 779 69; anna.strandqvist@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 4, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: When data will become available and for how long: Data will be available 6 months after publication of the primary trial results and will remain accessible for 5 years.
• Access Criteria: By what access criteria: Data will be available to qualified researchers for scientific purposes following submission of a research proposal and approval by the trial steering committee. Requests should be sent to the corresponding author or data custodian (contact information provided in the study publication).Data will be shared via a secure data repository

Locations

SE (1)