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CTRI Number  CTRI/2010/091/001063 [Registered on: 20/07/2010]
Last Modified On: 17/12/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug
Biological 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
A clinical trial to study the effect of R-TPR013 in patients undergoing treatment for infertility  
Scientific Title of Study
Modification(s)  
Prospective, multicentric, open label, clinical study to evaluate efficacy and safety of R-TPR-013 in patients undergoing treatment for infertility 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
RLS/TP/2010/02, ver; 02, dated 17/05/2010  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Sanjeev Hegde  
Designation  Head Clinical Development 
Affiliation  Reliance Life Science Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot No. R 282 TTC Area of MIDC Thane Belapur Road Rabale Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  02267678208  
Fax  02267678222  
Email  sanjeev.hegde@relbio.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Devi Manjula 
Designation  Head clinical Pharmacology 
Affiliation  Reliance Life Sciences Pvt Ltd  
Address  Reliance Clinical Research Services, CPR TOWERS, # 65-373-2, 100 ft.Ring Road,BTM Layout 2nd Stage,Bangalore

Bangalore
KARNATAKA
560001
India 
Phone  08066261111  
Fax  08066261196  
Email  devi.manjula@relbio.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Sanjeev Hegde 
Designation  Head Clinical Development 
Affiliation  Reliance Life Science Pvt. Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot No. R 282 TTC Area of MIDC Thane Belapur Road Rabale Navi Mumbai

Mumbai
MAHARASHTRA
400701
India 
Phone  02267678208  
Fax  02267678222  
Email  sanjeev.hegde@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt. Ltd. 
 
Primary Sponsor
Modification(s)  
Name  Reliance Life Sciences Pvt Ltd 
Address  Reliance Life Sciences Pvt. Ltd.,R-282, TTC Area of MIDC, Thane Belapur Road, Rabale. Mumbai MAHARASHTRA 400701 India R-282,Mumbai MAHARASHTRA 400701 India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Ranjit Joshi  Centre for Infertility and Endoscopy  2nd floor, Ganorkar hospital,Behind mahamarg bus stand, Mumbai naka,-422001
Nashik
MAHARASHTRA 


Ranjit@nasikwh.com 
Dr Nitin Lad  Dr. Lad?s Navjeevan Hospital  Tidke Colony, Ahilyabai Holkar Road, Near Mahamarg Bus Stop,-422002
Nashik
MAHARASHTRA 


lad.nitin@yahoo.com 
Dr.Madhuri Patil  Dr.Patil's Fertility & endoscopy clinic,center for assisted reproductive technology  first floor, Bannerghatta road,-560029
Bangalore
KARNATAKA 


drmadhurip@rediffmail.com 
Dr. Tity Chacko  Lakshmi Hospital  Diwan?s road,-682016

 


drtitychacko@gmail.com 
Dr. Sanjay Patel  Mayflower Women?s Hospital  Mayflower House, Memnagar,-380052
Ahmadabad
GUJARAT 


drymjhala@mayflowerhospital.com 
Dr. Manish Banker  Pulse Women?s Hospital  108, Swastik Society, Navrangpura,-380009
Ahmadabad
GUJARAT 


drbankar@pulse-hospitals.com 
Dr. Bharati Dhorepatil  Pune Fertility Centre  Crescent Exclusee, Behind Simla Office,1162/3,Shivaji Nagar,-411005
Pune
MAHARASHTRA 


bdhorepatil@gmail.com 
Dr. Ameet Patki  ReGenesis-Centre for Assisted Reproduction.  3rd Floor,Sadhana House,570,Pandurang Budhkar Marg,Worli,-400018
Mumbai
MAHARASHTRA 


ameet_patki@relbio.com 
Dr. Kamini Rao  Reproductive Medicine,BACC Health Care Pvt.Ltd  Kumara Krupa High grounds,-560001
Bangalore
KARNATAKA 


drkaminirao@gmail.com 
Dr. Kiran sekhar  Sai Kiran Hospital & Kiran infertility centre  besides nirmala high school, khairatabad,-500004
Hyderabad
ANDHRA PRADESH 


kiranivf@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Ethics Committee, Shatabadi Hospital, Mumbai Naka, Nasik  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
EthicsRUs, Mumbai  Approved 
Shree Hospital Ethics Committee Pune  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Female undergoing for treatment of Infertility 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  R-TPR-013  Dose- 0.25 mg, Frequency- R-TPR-013 will be administered at the dose of 250 μg as per individual’s response, Mode of Administration- Subcutaneous 
 
Inclusion Criteria
Modification(s)  
Age From   
Age To   
Gender   
Details  1. Patients with BMI between 18-29 kg/m2 (both inclusive) at the time of screening. 2. Female subjects age 18 years to 37 years (both inclusive) at the time of screening. 3. Infertile females of couples undergoing for controlled ovarian hyperstimulation (COH) 
 
ExclusionCriteria 
Details  1. History of clinically significant endocrine related abnormality 2. Any ovarian and/or abdominal abnormality interfering with ultrasound examination 3. History of clinically significant diseases e.g. epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease or PCOS 4. Subjects positive for HIV, HBsAg, HCV. 5. Subject participation in another clinical trial 30 days prior to administration of IP. 6. Any other condition which investigator feels would pose a significant hazard to subject if IP is administered. 7. Subject with history of alcohol or drug abuse within 12 months prior to signing informed consent. 
 
Method of Generating Random Sequence
Modification(s)  
Not Applicable 
Method of Concealment
Modification(s)  
Not Applicable 
Blinding/Masking
Modification(s)  
Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the efficacy of R-TPR-013.
 
Assessment of oocytes post R-TPR-013 administration 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Evaluation of safety  Evaluation of safety will be based on incidence of treatment-emergent adverse
events, abnormal clinical as well as laboratory results from baseline to end of the
study. 
 
Target Sample Size
Modification(s)  
Total Sample Size="102"
Sample Size from India="102" 
Phase of Trial
Modification(s)  
Phase 3 
Date of First Enrollment (India)
Modification(s)  
No Date Specified 
Date of First Enrollment (Global)  22/07/2010 
Estimated Duration of Trial
Modification(s)  
Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary
Modification(s)  

This study is a prospective, open label, multicentric trial to evaluate the efficacy and safety of R-TPR-013 in females undergoing treatment for Infertility. The study will be conducted in 10 centers across India. Primary end point will be evaluation of oocyte after R-TPR-013 administration. The secondary end point will be evaluation of safety. 

 
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