Hypothalamic Amenorrhea, FunctionalNCT06933888
Assessment of Nutritional Knowledge, Habits, and Eating Behavior in Athletic Women to Evaluate the Possible Impact on Their Menstrual Function
An observational study of Hypothalamic Amenorrhea, Functional, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 30 years, women only
- Conditions the study is for
- Hypothalamic Amenorrhea, Functional
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2021to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Young athletic women referred for menstrual dysfunction of non-organic causes
Who may be able to join
- Female sex
- Age 16-30 years
- Physical activity > 2 days per week
- Informed consent from the patient and/or an authorized legal representative
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo, SSD Ostetricia e Ginecologia 2 - Riproduzione e Procreazione Medicalmente Assistita
Pavia, Pavia, 27100
Rossella Nappi, MD, +390382503325, r.nappi@smatteo.pv.it
About this study
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).
- Conditions
- Hypothalamic Amenorrhea, Functional
- Keywords
- Functional Hypothalamic Amenorrhea, Eating disorders
- Medical subject headings
- Feeding and Eating Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Assessment of nutritional knowledge through GeSNK questionnaire in women with menstrual dysfunction of non-organic cause other than functional hypothalamic amenorrhea
Measured: 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
Assessment of eating habits and nutritional intake through a food diary to identify the presence of low energy availability.
Measured: 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.
Assessment of Low Energy Availability in Females questionnaire [LEAF-Q]
Measured: 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.
Assessment of Eating Attitude Test 26 [EAT-26]
Measured: 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.
Assessment of Eating Disorder Inventory -2 [EDI-2]
Measured: 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.
Assessment of ORTO-15 questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start13 Sep 2021
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic Amenorrhea, FunctionalStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossella Nappi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933888
- Sponsor's protocol ID
- P_6620
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nutritional Knowledge, Habits, and Eating Behavior in Athletic Women to Evaluate the Possible Impact on Their Menstrual Function
- ClinicalTrials.gov ID
- NCT06933888
- Acronym / sponsor ID
- P_6620
- Conditions
- Hypothalamic Amenorrhea, Functional
- Keywords
- Functional Hypothalamic Amenorrhea, Eating disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Young athletic women referred for menstrual dysfunction of non-organic causes
Key inclusion criteria (4 listed)
- Female sex
- Age 16-30 years
- Physical activity > 2 days per week
- Informed consent from the patient and/or an authorized legal representative
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess nutritional knowledge in athletic women with functional hypothalamic amenorrhea
Time frame: Baseline
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.
6 secondary outcomes
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothalamic Amenorrhea, Functional, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rossella Nappi, MD (0382503325, r.nappi@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess nutritional knowledge in athletic women with functional hypothalamic amenorrhea (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.