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CTRI Number  CTRI/2024/09/074374 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 20/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Optimal treatment regimen for PCOS (polycystic ovary syndrome) 
Scientific Title of Study   To find out the optimal treatment regimen for PCOS 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rama Walia 
Designation  Additional Professor 
Affiliation  Post graduate institute of medical education and research. 
Address  Room no 9, Endocrinology department, ground floor, Nehru Hospital Extension,Post graduate institute of medical education and research.

Chandigarh
CHANDIGARH
160012
India 
Phone  9872997438  
Fax    
Email  ramawaliapgimer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rama Walia 
Designation  Additional Professor 
Affiliation  Post graduate institute of medical education and research. 
Address  Room no 9, Endocrinology Department, ground floor, Nehru hospital extension, Post graduate institute of medical education and research.

Chandigarh
CHANDIGARH
160012
India 
Phone  9872997438  
Fax    
Email  ramawaliapgimer@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rama Walia 
Designation  Additional Professor 
Affiliation  Post graduate institute of medical education and research. 
Address  Room no 9, Endocrinology department, ground floor, Nehru hospital extension, Post graduate institute of medical education and research.

Chandigarh
CHANDIGARH
160012
India 
Phone  9872997438  
Fax    
Email  ramawaliapgimer@gmail.com  
 
Source of Monetary or Material Support  
Endocrine Society of India, Beleghata main road ,Kulia, Beleghata , Kolkata , West Bengal. 
 
Primary Sponsor  
Name  PGIMER Postgraduate Institute of Medical education and Research 
Address  sector 12, Chandigarh,160012,India. 
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 Rama Walia  PGIMER  Room 9, Endocrinology department, ,ground floor, Nehru Hospital Extension, Post graduate institute of medical education and research., Chandigarh.
Chandigarh
CHANDIGARH 		 9872997438

ramawaliapgimer@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PGIMER, INSTITUTIONAL ETHICS COMMITTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  metformin spironolactone dutasteride  metformin 1g BD spironolactone from day 5 to day 25 of cycle in dose 50 to 200mg per day OD dutasteride 0.5mg HS all given for 9 months 
Comparator Agent  Oral contraceptive pill- Novelon spironolactone  oral contraceptive pill (novelon) from day1 to day21 of menstrual cycle daily spironolactone in the dose of 25 to 200mg per day. both given for 9 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  age more than 18 years
BMI less than 25 kg/m2
pcos diagnosed by rotterdam criteria ( phenotype 1, 2 and 3) 
 
ExclusionCriteria 
Details  age more than 40 years
chronic illness
acute infection
malignancy
type 2 diabetes 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
free androgen index  at baseline then at 9 months of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
menstrual cycle regulation,
improvement in hirsutism,
HOMA IR, glucose tolerance, lipid profile,
improvement in glucose tolerance
improvement in bone health
changes in blood levels of FSH , LH , Prolactin , estradiol, cortisol, AMH, SHBG , DHEAS.
change in ovarian volume
improvement in quality of life
change in levels of oxyandrogens  		 menstrual cycle regulation & improvement in hirsutism at 3 monthly intervals.Rest all at baseline & then at 9 months of treatment. 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   Phase 3 
Date of First Enrollment (India)   27/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ramawaliapgimer@gmail.com].

  6. For how long will this data be available start date provided 05-09-2024 and end date provided 05-09-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   PCOS is the most common endocrinopathy in reproductive aged females. Most of the time standard treatment is Oral contraceptive pills which on long term use has multiple side effects. With this trial we want to find out optimal non OCP treatment regime of PCOS. 
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