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Screening Women for Functional Hypothalamic Amenorrhea (FHA)

A Questionnaire-based Study to Improve the Diagnosis of Functional Hypothalamic Amenorrhea (FHA) in Women With Secondary Amenorrhea Attending Hospital

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05410886
Enrollment
20
Registered
2022-06-08
Start date
2021-02-11
Completion date
2024-02-02
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amenorrhea Secondary

Brief summary

What do the investigators know already? Many women suffer loss of periods (amenorrhoea). One of the most common causes of period loss is called 'functional hypothalamic amenorrhea' (FHA). FHA is difficult to diagnose and may be mistaken for other conditions causing period loss, such as polycystic ovarian syndrome (PCOS). This could cause delays in starting the correct treatment. What is the justification for doing this study? Undiagnosed women with FHA are predisposed to complications related to low oestrogen levels, such as osteoporosis, bone fractures and infertility. The failure to accurately identify women with FHA and mislabel those women with FHA as having PCOS, may delay appropriate treatment. Treatment delay causes harm for affected women, including bone fractures and infertility. What do the investigators propose? Improve the diagnosis of women with FHA by composing an assessment score, which could be used by women to improve the accuracy of diagnosing FHA. The investigators designed a questionnaire based on literature search, which can be used to identify women with FHA. A questionnaire-based study (on-line or in person) will be performed to identify risk of FHA, in women referred to hospital with period loss.

Detailed description

A questionnaire was developed to be used by women with period loss to facilitate the diagnosis of women with FHA. The development of the questionnaire was based on systematic literature review and comments from a small patient involvement group, as per National Institute for Health and Care Research (NIHR) INVOLVE guidelines. Participants will be recruited via distributing a patient information sheet, consent form and a questionnaire to all women referred with amenorrhea to the Endocrinology or Reproductive Medicine clinics at Imperial College Healthcare NHS Trust and/or participating NHS organisations. Completion of the consent form and questionnaire is entirely dependent on each potential participant's choice. Every woman taking part can complete the questionnaire before or after her appointment. All questionnaires will be anonymised with a unique study code, and handed back to the NHS clinician.

Interventions

OTHERQuestionnaire

A questionnaire including up to 20 questions will be distributed to study participants. This questionnaire will be used to identify women with FHA.

Sponsors

University College, London
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 58 Years
Healthy volunteers
No

Inclusion criteria

* Any woman 18-58 years of age * Secondary amenorrhea defined by either menstrual cycle interval persistently exceeding 45 days and/or those with period loss for 3 months or more

Exclusion criteria

* Women who never had periods (primary amenorrhea).

Design outcomes

Primary

MeasureTime frameDescription
Frequency of clinical features in women with Functional hypothalamic amenorrhea3 yearsDescriptive statistics will be applied to questionnaire responses looking at frequency of different clinical features in women with FHA and women with other diagnoses.

Other

MeasureTime frameDescription
Frequency of biochemical features in women with Functional hypothalamic amenorrhea3 yearsDescriptive statistics will be applied to standard medical investigation results looking at frequency of different biochemical features in women with FHA and women with other diagnoses.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026