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CTRI Number  CTRI/2012/08/002845 [Registered on: 01/08/2012] Trial Registered Retrospectively
Last Modified On: 29/06/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Efficacy of different drugs like Clomiphene with or without Metformin/ Pioglitazone/ Spironolactone in Polycystic Ovary syndrome. 
Scientific Title of Study   Efficacy of Clomiphene with or without Metformin/Pioglitazone/ Spironolactone in patients with Polycystic Ovary syndrome.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1 10/02/2010  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sunita J Ramanand  
Designation  Associate Professor 
Affiliation  Govt. Medical College, Miraj 
Address  Department Of Pharmacology Govt. Medical College, Miraj

Sangli
MAHARASHTRA
416410
India 
Phone  09850547900  
Fax    
Email  pharmac.ctri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunita J Ramanand  
Designation  Associate Professor 
Affiliation  Govt. Medical College, Miraj 
Address  Department Of Pharmacology Govt. Medical College, Miraj

Sangli
MAHARASHTRA
416410
India 
Phone  09850547900  
Fax    
Email  pharmac.ctri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sunita J Ramanand  
Designation  Associate Professor 
Affiliation  Govt. Medical College, Miraj 
Address  Department Of Pharmacology Govt. Medical College, Miraj

Sangli
MAHARASHTRA
416410
India 
Phone  09850547900  
Fax    
Email  pharmac.ctri@gmail.com  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr Sunita J Ramanand 
Address  DEPT OF PHARMACOLOGY, GOVT MEDICAL COLLEGE MIRAJ 
Type of Sponsor  Other [Dr Sunita J Ramanand] 
 
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 Sunita J Ramanand   Room no 1 , Research Lab,Department of Pharmacoogy,Government Medical College Miraj   Room no 1 Research Lab division Department of Pharmacoogy Government Medical College Miraj Pandharpur Road Miraj
Sangli
MAHARASHTRA 		 09850547900

pharmac.ctri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Govt Medical College Miraj   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Polycystic ovary syndrome ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clomiphene  Tablet Clomiphene 50 mg/day orally for 3 months  
Intervention  Metformin, pioglitazone, spironolactone  Tablet Metformin 750 mg per day orally increased to 1500mg per day orally if desired for 3 months Tablet Pioglitazone 15 mg per day orally for 3 months Tablet Spironolactone 25 mg once a day orally and increased upto 75 mg if not showing adequate response for 3 months  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details 
A) Clinical criteria:
1.oligomenorrhea or menstrual disturbances
3.S/S of Hyperandrogenism viz, acne, hirsuitism, alopecia.
4.Acanthosis nigricans.
B) Hormonal criteria:
1.LH/FSH ratio >1.5
2.Serum Testosterone >1.1 ng/ml
C) Abdominal USG:
At least 10 follicles (2-8 mm in diameter) arranged peripherally around a dense core of ovarian stroma or scattered throughout an increased amount of stroma.
Patient of PCOD having hypothyroidism will be treated with thyroxine. After achieving euthyroid states, patient will be included in the study.
 
 
ExclusionCriteria 
Details  1) Systemic diseases- Renal, hepatic cardiac, RS , frank DM, hypertension ,
congenital adrenal hyperplasia, ,hyperprolactinemia, acromegaly, functional hypothalamic amenorrhea.
2) Past H/O lactic acidosis.
3) Patients undergoing IV contrast media study or surgical procedures.
4) BMI ( >30 mg/) kg

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Regularisation of menses   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in clinical features of PCOS  3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 4 
Date of First Enrollment (India)   29/04/2010 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

               Polycystic ovary syndrome (PCOS ) is one of the most common endocrinological disorders, may present with amenorrhea, infertility, hyperandrogenism, metabolic disturbances like insulin resistance, dyslipidemia.  Presence of insulin resistance, obesity, dyslipidemia places them in high risk of developing diabetes and cardiovascular disorders.Ovulation inducers like Clomiphene  are first line drugs in PCOS, insulin sensitizers like  metformin, Thiazolidinediones  like Pioglitazone and antiandrogens  like Spironolactone  can be of help in PCOS.Previous multiple studies have compared Clomiphene with metformin, Pioglitazone and its combination with these drugs . Present research   plans to do compare these drugs alone or in combination in a single study. 

 
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