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CTRI Number  CTRI/2022/01/039237 [Registered on: 07/01/2022] Trial Registered Prospectively
Last Modified On: 17/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Vaginal (Menstrual) Cup]  
Study Design  Other 
Public Title of Study   Acceptability and performance of menstrual cup. 
Scientific Title of Study   Acceptability and Performance of menstrual cup versus conventional methods for menstrual hygiene in Reproductive Age Group women in selected states in India 
Trial Acronym  MM 
Secondary IDs if Any  
Secondary ID  Identifier 
NA  NIL 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mamta parihar 
Designation  Lecturer 
Affiliation  Dr. S.N. Medical College Jodhpur 
Address  Govt college of nursing Dr SN Medical college Dept of medical surgical Nursing, ground flour, Room no. 16 MDM hospital campus near girls PG college, Kewal chand modi marg, shastri nagar, Jodhpur
D. K. Tailor’s, Paota rasala road, II floor, Room no. 2 Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09529794077  
Fax    
Email  mamtaparihar2011@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mamta parihar 
Designation  Lecturer 
Affiliation  Dr. S.N. Medical College Jodhpur 
Address  Govt college of nursing Dr SN Medical college Dept of medical surgical Nursing, ground flour, Room no. 16 MDM hospital campus near girls PG college, Kewal chand modi marg, shastri nagar, Jodhpur
D. K. Tailor’s, Paota rasala road, II floor, Room No. 2 Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09529794077  
Fax    
Email  mamtaparihar2011@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mamta parihar 
Designation  Lecturer 
Affiliation  Dr. S.N. Medical College Jodhpur 
Address  Govt college of nursing Dr SN Medical college Dept of medical surgical Nursing, ground flour, Room no. 16 MDM hospital campus near girls PG college, Kewal chand modi marg, shastri nagar, Jodhpur
D. K. Tailor’s, Paota rasala road, II Floor, Room No. 2 Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09529794077  
Fax    
Email  mamtaparihar2011@gmail.com  
 
Source of Monetary or Material Support  
She cup Enterprises 
 
Primary Sponsor  
Name  She Cup agency MediAseso Pvt Ltd 
Address  1st Floor 98 VP Road CP Tank Mumbai 400 004 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mahaveer   Aanganwari Center, Asha coordinator  Chief Medical Health Office, I GF Room No. 3 Jhalamand Jodhpur
Jodhpur
RAJASTHAN 		 9950130607

mahaveerj@gmail.com 
Sumi Mathew  Government Nursing College, Dr. SN Medical college Jodhpur  Ground floor Staff room no.15 MDM hospital campus near Girls PG Hostel Shastri Nagar
Jodhpur
RAJASTHAN 		 9530180206

sumijlawrence@gmail.com 
Ritu shrotriya  Naari Niketan   Department of social justice and women and child health, first floor, Room No. 2 9 meel Mandore, near Police Station
Jodhpur
RAJASTHAN 		 9460008211

ritu.magu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Government Nursing CollegeJodhpur  Approved 
Human Research ethical committee, Udaipur  Approved 
Naari Niketan Jodhpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  women of reproductive age group with normal menstrual cycle, with no vaginal or urinary infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional Methods  Sanitary Pads or Cloth for at least 3 months, however any participant can use it longer 
Intervention  Menstrual Cup  For at least 3 month however any participant can use it longer if she is interested Menstrual cup is a silicon made device which can be worn inside the vagina to catch or collect menstrual blood  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  The reproductive age group of women of 15 to 50 years (however the inclusion criteria is participants with menstrual phase) 
 
ExclusionCriteria 
Details  Women with known silicon allergy, uterovaginal infection or fistula, pregnant or intendant to become pregnant 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Acceptability and performance of a menstrual cup to manage the periods  Three months 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life, comfort, physical activities during menstruation  three months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
Final Enrollment numbers achieved (Total)= "747"
Final Enrollment numbers achieved (India)="747" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/01/2022 
Date of Study Completion (India) 24/12/2023 
Date of First Enrollment (Global)  01/02/2022 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Parihar M, Ajmera V, Abbott-Anderson K, “Menstrual freedom -Experiences of reproductive age group women after using a menstrual cup in selected areas in Rajasthan (India).”INT-JECSE.2023 Dec: 15(2) p. 660 – 667. Available from: https://www.int-jecse.net/article DOI: 10.48047/INTJECSE/V15I2.88 Parihar M, Ajmera V, Abbott-Anderson K, Sahoo KC. “A Qualitative Study – “This is Why Women reject to use a Menstrual Cup – Experiences of Non-Users.” JCHR , 2024 Jan; 14(1) p.1489-1459. Available from: https://jchr.org/index.php/JCHR/article/view/2626DOI: https://doi.org/10.52783/jchr.v14.i01.2626 Theses studies are grounded on the main study however the main study publication is in the process. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Introduction: Preventive measures for health care are paramount to adopt a sustainable and healthy alternative for menstrual Hygiene management. The number of cervical cancer patients is increasing due to the unhygienic menstrual hygiene practices. The chemicals present in sanitary pads are fatal carcinogens.

Aim: The aim of the study was to compare the acceptability and performance of the menstrual cup versus conventional methods.

Methodology: A concurrent mixed-method approach was used. The women were assessed for their preferred menstrual hygiene management practice, and in-depth and focused group interviews were conducted to further explore the factors for opting for a particular menstrual method. A total of 747 reproductive age group women (15-49) of India were selected. Identical concurrent sampling was used. The setting of the study was selected by multistage sampling, and four institutions from four zones of India (East, West, North, South) were selected. Data analysis was done by using SPSS 23 and MAXQDA software.

Results: The results showed that out of 747 participants, only 67 were using a menstrual cup and 680 were using conventional methods. Higher acceptability and performance rate found in menstrual cup users as 81% and 76.1% whereas for the conventional methods, it was 26.5% and 27.2% respectively. A positive correlation was found between acceptability and performance of the menstrual cup and conventional methods.

Conclusion: If women are provided with training on how to use a menstrual cup with a proper follow-up, they can easily adapt to a more sustainable and healthy solution for menstrual hygiene.

Key words: Menstrual cup, Conventional Methods, Reproductive age group women.

 
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