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El ensayo clínico NCT07386223 (HEAL-FHA) para Hypothalamic Amenorrhea, Functional está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí.
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Health and Lifestyle Support for Functional Hypothalamic Amenorrhea (HEAL-FHA) 70 Estilo de vida

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El ensayo clínico NCT07386223 (HEAL-FHA) es un estudio intervencionista para Hypothalamic Amenorrhea, Functional. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de febrero de 2026 hasta completar 70 participantes. Dirigido por el Instituto Karolinska, se espera que finalice el 31 de diciembre de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 4 de febrero de 2026.
Resumen
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 an...

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Descripción detallada
The study a randomized, controlled, multicentre trial evaluating a 10-week psychoeducational health and lifestyle intervention with a 9-month follow-up period in women with Functional Hypothalamic Amenorrhea (FHA).

Background and Significance FHA is a functional endocrine condition that can be reversed through behavioural and lifestyle changes. A structured psychoeducational program may support these changes by impr...

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Título oficial

HEAL-FHA: Health and Lifestyle Support for Functional Hypothalamic Amenorrhea

Condiciones médicas
Hypothalamic Amenorrhea, Functional
Otros ID del estudio
  • HEAL-FHA
  • 2023-05586-01
Número del NCT
NCT07386223
Inicio del estudio (real)
2026-02-01
Última actualización
2026-02-04
Fecha de finalización (estimada)
2028-12-31
Inscripción (prevista)
70
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Palabras clave
psychoeduction
lifestyle change
menstrual restoration
amenorrhea
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
ExperimentalPsychoeducational Intervention
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. Part...Mostrar más
Psychoeducaction or treatment as usual
10 week psychoeducaction or treatment as usual
Comparador activoTreatment as Usual (TAU)
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.
Tratamiento habitual (TAU)
Standard FHA management provided in routine clinical care.
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
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
Asistente de participación
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Mujer
  • female
  • aged 18-42 years
  • fulfill criteria for diagnosis of functional hypothalamic amenorrhea (hypogonadotropic hypogonadism)
  • basic proficiency in Swedish
  • access to a computer.

  • Lack of proficiency in language
  • evere psychiatric co-morbidity e.g. psychosis or active eating disorders (anorexia nervosa).
Karolinska Institutet logoInstituto Karolinska
  • Karolinska University Hospital logoKarolinska University Hospital
  • FoU Centrum, Landstinget Sörmland logoFoU Centrum, Landstinget Sörmland
Parte responsable del estudio
Hedvig Engberg, Investigador principal, Assistant Professor, Karolinska Institutet
Contactos centrales del estudio
Contacto: Hedvig Engberg, MD PhD, +46 08 123 795 02, [email protected]
Contacto: Anna Strandqvist, PhD, +46 08 123 779 69, [email protected]
1 Centros del estudio en 1 países
Kvinnohälsan Karolinska Universitetssjukhuset, Stockholm, Sweden