Screening Women for Functional Hypothalamic Amenorrhea (FHA)

NCT05410886 | Completed

• 1 other identifier: 20HH6115
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Amenorrhea Secondary

Outcome Measures

Primary Outcomes (1)

• Frequency of clinical features in women with Functional hypothalamic amenorrhea

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

  3 years

Other Outcomes (1)

• Frequency of biochemical features in women with Functional hypothalamic amenorrhea

  3 years

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All women referred by their GP with amenorrhea to the Endocrinology or Reproductive Medicine clinics at Imperial College Healthcare NHS Trust hospitals and participating NHS organisations.

You may qualify if:

• 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

You may not qualify if:

• Women who never had periods (primary amenorrhea).

Sponsors & Collaborators

• Imperial College London: lead
• University College, London: collaborator

Study Sites (2)

University College London Hospital NHS Trust

London, NW1 2BU, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (2)

• Phylactou M, Clarke SA, Patel B, Baggaley C, Jayasena CN, Kelsey TW, Comninos AN, Dhillo WS, Abbara A. Clinical and biochemical discriminants between functional hypothalamic amenorrhoea (FHA) and polycystic ovary syndrome (PCOS). Clin Endocrinol (Oxf). 2021 Aug;95(2):239-252. doi: 10.1111/cen.14402. Epub 2021 Jan 19.

  PMID: 33354766 BACKGROUND

• Abou Sherif S, Newman R, Haboosh S, Al-Sharefi A, Papanikolaou N, Dimakopoulou A, Webber LJ, Abbara A, Franks S, Dhillo WS, Jayasena CN. Investigating the potential of clinical and biochemical markers to differentiate between functional hypothalamic amenorrhoea and polycystic ovarian syndrome: A retrospective observational study. Clin Endocrinol (Oxf). 2021 Oct;95(4):618-627. doi: 10.1111/cen.14571. Epub 2021 Aug 9.

  PMID: 34323305 RESULT

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Channa Jayasean, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: February 11, 2021
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

GB (2)