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CTRI Number  CTRI/2025/07/091288 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 13/06/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   pilot study 
Study Design  Other 
Public Title of Study   Development of scale for perception of athletic amenorrhea among female university athletes  
Scientific Title of Study   Development and validation of knowledge, attitude and perception of athletic amenorrhea among female university athletes  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVasudha Siddappa  
Designation  Assistant professor  
Affiliation  KLE institute of physiotherapy belagavi Nehru Nagar  
Address  KLE dr.Prabhakar kore hospital and advanced physiotherapy centre orthopaedic manual department room no.13 ,advance Physiotherapy centre room no. 39 ,sagar word

Belgaum
KARNATAKA
590010
India 
Phone  8884937546  
Fax    
Email  vasudhasiddappa@klekipt.edu.in   
 
Details of Contact Person
Scientific Query  
Name  DrVasudha Siddappa  
Designation  Assistant professor  
Affiliation  KLE institute of physiotherapy Belagavi Nehru Nagar  
Address  Advanced Physiotherapy center,department of pediatric physiotherapy, room no 39, sagar floor, Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  8884937546  
Fax    
Email  vasudhasiddappa@klekipt.edu.in   
 
Details of Contact Person
Public Query  
Name  Samruddhi Deshpande  
Designation  Physiotherapy intern  
Affiliation  KLE institute of Physiotherapy  
Address  K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, Advanced Physiotherapy Centre, OMT department OPD no.39, Nehru Nagar Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8147836290  
Fax    
Email  deshpandesamruddhidell@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr Prabhakar Kore hospital and research centre, Nehru Nagar, Belgaum 
 
Primary Sponsor  
Name  KAHER Institute of Physiotherapy 
Address  KAHER Institute of Physiotherapy, JNMC Campus, Nehru Nagar, Belagavi - 590010  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vasudha Siddappa   KAHER institute of Physiotherapy   K.L.E.S Prabhakar Kore Hospital and Medical Research centre, Sagar Floor, room no. 13 .Advanced Physiotherapy Centre, OMT department OPD no.39, Nehru Nagar, Belagavi 590010
Belgaum
KARNATAKA 		 88849 37546

vasudhasiddappa@klekipt.edu.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethical committee of KAHER institute of physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  5 experts in obg and sports  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  26.00 Year(s)
Gender  Female 
Details  female athletes between e age group of 19 to 26 years
recreational female athletes of Belagavi university
recreational female athletes who train for at least 1 hour  
 
ExclusionCriteria 
Details  Female athletes unwilling to participate.
Participants with diagnosed medical conditions that could affect menstrual health such as thyroid disorders or polycystic ovarian syndrome
Female athletes who participate in Elite sports.
Female athletes who have primary amenorrhea. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
development and validation of a questionnaire to assess the knowledge, attitude and perception of athletic amenorrhea among female university   development and validation of a questionnaire to assess the knowledge, attitude and perception of athletic amenorrhea among female university
Between the age of 19 to 26 years  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/08/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included vasudhasiddappa@gmail.com).

  6. For how long will this data be available start date provided 20-06-2025 and end date provided 30-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Athletic amenorrhea is a significant yet often underestimated health issue among female athletes. While training and performance are prioritized, High levels of physical exertion, especially when not matched by adequate caloric intake, can suppress the hypothalamic-pituitary-ovarian (HPO) axis, leading to hormonal imbalances and menstrual disruption.

Left unmanaged, these imbalances may compromise reproductive health, bone strength, and long-term athletic performance the potential risks associated with menstrual irregularities are frequently overlooked.

A lack of awareness about this condition can result in serious long-term health complications, such as infertility, osteoporosis, and an increased risk of fractures, all of which can negatively impact an athlete’s career and overall well-being. Despite its common occurrence, many female athletes have limited knowledge about athletic amenorrhea. Missed periods are often disregarded or even seen as a normal part of intense training rather than a warning sign of underlying health concerns

The absence of proper education and guidance further delays diagnosis and appropriate intervention. Hence the need arises to evaluate awareness level among female university athletes regarding athletic amenorrhea and its impact.

 
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