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O estudo clínico NCT07386223 (HEAL-FHA) para Hypothalamic Amenorrhea, Functional está ainda não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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Health and Lifestyle Support for Functional Hypothalamic Amenorrhea (HEAL-FHA) 70 Estilo de vida

Ainda não recrutando
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O estudo clínico NCT07386223 (HEAL-FHA) é um estudo intervencionista para Hypothalamic Amenorrhea, Functional. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 1 de fevereiro de 2026, com o objetivo de incluir 70 participantes. Coordenado por o Instituto Karolinska e deve ser concluído em 31 de dezembro de 2028. Essas informações foram atualizadas no ClinicalTrials.gov em 4 de fevereiro de 2026.
Resumo
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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Descrição detalhada
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

Condições médicas
Hypothalamic Amenorrhea, Functional
Outros IDs do estudo
  • HEAL-FHA
  • 2023-05586-01
Número NCT
NCT07386223
Data de início (real)
2026-02-01
Última atualização postada
2026-02-04
Data de conclusão (estimada)
2028-12-31
Inscrição (estimada)
70
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
psychoeduction
lifestyle change
menstrual restoration
amenorrhea
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
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 mais
Psychoeducaction or treatment as usual
10 week psychoeducaction or treatment as usual
Comparador ativoTreatment 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.
Tratamento como de costume (TAU)
Standard FHA management provided in routine clinical care.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Adulto
Idade mínima
18 Years
Sexos elegíveis
Feminino
  • 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
Responsável pelo estudo
Hedvig Engberg, Investigador principal, Assistant Professor, Karolinska Institutet
Contato central do estudo
Contato: Hedvig Engberg, MD PhD, +46 08 123 795 02, [email protected]
Contato: Anna Strandqvist, PhD, +46 08 123 779 69, [email protected]
1 Locais do estudo em 1 países
Kvinnohälsan Karolinska Universitetssjukhuset, Stockholm, Sweden