NCT06933888

Brief Summary

The present study aims to investigate the degree of knowledge about nutrition and dietary habits in athletic women through validated questionnaires and to evaluate a possible impact on their menstrual function, including women with a diagnosis of functional hypothalamic amenorrhea (FHA) and women who present with a different menstrual dysfunction (oligomenorrhea or polymenorrhea in absence of organic causes).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

March 27, 2025

Last Update Submit

April 10, 2025

Conditions

Keywords

Functional Hypothalamic AmenorrheaEating disorders

Outcome Measures

Primary Outcomes (1)

  • Assess nutritional knowledge in athletic women with functional hypothalamic amenorrhea

    The outcome will be assessed with a single measurement through a validated questionnaire (General and Sport Nutrition Knowledge \[GeSNK\]). More specifically, the proportion of subjects with moderate knowledge (score between 46 and 58) will be evaluated.

    Baseline

Secondary Outcomes (6)

  • Evaluation of nutritional knowledge in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.

    Baseline

  • Assessment of eating habits in in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases

    Baseline

  • Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.

    Baseline

  • Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.

    Baseline

  • Evaluation of eating behavior in athletic women with menstrual dysfunctions of different nature, comparing women with FHA to those with oligomenorrhea/polymentorrhea in the absence of organic diseases.

    Baseline

  • +1 more secondary outcomes

Eligibility Criteria

Age16 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young athletic women referred for menstrual dysfunction of non-organic causes

You may qualify if:

  • Female sex
  • Age 16-30 years
  • Physical activity \> 2 days per week
  • Informed consent from the patient and/or an authorized legal representative

You may not qualify if:

  • Menstrual disorders of organic cause (ovarian cysts, uterine fibroids, polyps, etc.)
  • Concomitant non-reproductive organic diseases (hypertension, diabetes, etc.)
  • Use of psychopharmacological therapies
  • Language barrier

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Rossella Nappi, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 18, 2025

Study Start

September 13, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

April 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations