| 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)
|
|
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. |