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Completed

NCT Number: NCT05410886

Screening Women for Functional Hypothalamic Amenorrhea (FHA)

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.

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Key information

Conditions

Amenorrhea Secondary

Age range

18 year–58 year

Sex eligibility

Female

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Frequency of clinical features in women with Functional hypothalamic amenorrhea

    Time frame: 3 years

    Descriptive statistics will be applied to questionnaire responses looking at frequency of different clinical features in women with FHA and women with other diagnoses.

Other outcomes

  1. Frequency of biochemical features in women with Functional hypothalamic amenorrhea

    Time frame: 3 years

    Descriptive 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • University College, London

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2022
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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