Screening Women for Functional Hypothalamic Amenorrhea (FHA)

June 8, 2022 updated by: Imperial College London

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
      • London, United Kingdom, NW1 2BU
        • Not yet recruiting
        • University College London Hospital NHS Trust
        • Contact:
          • Anastasia Dimakopoulou
          • Phone Number: 00447757640652

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

University College, London

Investigators

  • Principal Investigator: Channa Jayasean, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20HH6115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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