CTRI/2011/07/001874 [Registered on: 11/07/2011] Trial Registered Prospectively
Last Modified On:
10/10/2012
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Medical Device
Study Design
Non-randomized, Active Controlled Trial
Public Title of Study
Evaluation of Progesterone vaginal ring v/s Cu T 380 A IUD in lactating women
Scientific Title of Study
Evaluation of a progesterone vaginal ring as a new contraceptive option in India
Trial Acronym
PVR study
Secondary IDs if Any
Secondary ID
Identifier
418
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Malabika Roy
Designation
Scientist F
Affiliation
Indian Council of Medical Research (ICMR)
Address
Division of Reproductive Health and Nutrition,
Indian Council of Medical Research, V. Ramalingaswami Bhavan, Ansari Nagar, New Delhi -110029, India 777, Asian Games Village Complex, New Delhi - 110049 New Delhi DELHI 110029 India
Phone
011-26588965
Fax
011-26588755
Email
malaroy69@gmail.com
Details of Contact Person Scientific Query
Name
Dr Malabika Roy
Designation
Scientist F
Affiliation
Indian Council of Medical Research (ICMR)
Address
Division of Reproductive Health and Nutrition,
Indian Council of Medical Research, V. Ramalingaswami Bhavan, Ansari Nagar, New Delhi -110029, India 777, Asian Games Village Complex, New Delhi - 110049 New Delhi DELHI 110029 India
Phone
011-26588965
Fax
011-26588755
Email
malaroy69@gmail.com
Details of Contact Person Public Query
Name
Dr Malabika Roy
Designation
Scientist F
Affiliation
Indian Council of Medical Research (ICMR)
Address
Division of Reproductive Health and Nutrition,
Indian Council of Medical Research, V. Ramalingaswami Bhavan, Ansari Nagar, New Delhi -110029, India 777, Asian Games Village Complex, New Delhi - 110049 New Delhi DELHI 110029 India
Phone
011-26588965
Fax
011-26588755
Email
malaroy69@gmail.com
Source of Monetary or Material Support
Department of Biotechnology
Ministry of Science & Technology
Block – 2, 7th floor, C.G.O Complex
Lodi road, New Delhi - 110003
Primary Sponsor
Name
Indian Council of Medical Research
Address
Division of Reproductive Health and Nutrition
Indian Council of Medical Research
Ansari Nagar
New Delhi 110029 India
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
Population Council USA
Population Council
Center for Biomedical Research
1230 York Avenue
New York, NY 10065
USA
Countries of Recruitment
India
Sites of Study
No of Sites = 20
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Suneeta Mittal
All India Institute of Medical Sciences
Room No 3080,3rd floor
Teaching Block
Department of Obstetrics and Gynecology
All India Institute of Medical Sciences, Ansari Nagar,
New Delhi - 110029
India New Delhi DELHI
01126593378 01126588449 suneeta_mittal@yahoo.com
Dr Vineeta Das
Chhatrapati Shahuji Maharaj Medical University, Lucknow
Prof and HOD
Institute of Obstetrics and Gynecology
Chhatrapati Shahuji Maharaj Medical University
Lucknow- 226003
Lucknow UTTAR PRADESH
05222257742 05222257539 das_lko@yahoo.com
Dr Tapan Kumar Lahiri
EDEN, KOLKATA
Prof and Head
Institute of Obstetrics and Gynecology
Medical College & Eden Hospital
Kolkata -700073
Kolkata WEST BENGAL
03322144901
ahiritapan@yahoo.co.in
Dr Guru Prasad Pednekar
Goa Medical College, GOA
Prof and Head,
Dept of Obstetrics and Gynecology
Goa Medical College,
Goa - 403202
North Goa GOA
08322458911 08322458728 goahrrc408@yahoo.com
Dr Shashi Gupta
Govt Medical College, SMGS Hospital, Jammu
Prof and Head
Department of Obstetrics and Gynecology
Govt Medical College, SMGS Hospital,
Shalimar Road
Jammu 180001
Jammu JAMMU & KASHMIR
01912547635 01912584247 drshashi.gupta@yahoo.com
Dr RG Davar
Grants Medical College, Mumbai
Prof and Head
Balaram Building, 4th floor
Department of Obstetrics & Gynecology
Grants Medical College and Sir J.J. Group of Hospitals, Byculla,
Mumbai - 400008
Mumbai MAHARASHTRA
02223706332 02223735599 sunillataicmr@gmail.com
Dr Kiran Pandey
GSVM Medical College, Kanpur
Prof and Head
Department of Obstetrics and Gynecology
GSVM Medical College
Kanpur 208002
Kanpur Nagar UTTAR PRADESH
05122543855
dr.kiranpandey@gmail.com
Dr P Meenalochani
Institute of Obstetrics and Gynecology,Chennai
Prof and HOD
Institute of Obstetrics and Gynecology
Institute of Obstetrics and Gynecology and Hospital for women & Children, Chennai - 600008 Chennai TAMIL NADU
04428193094 04428194118 hrrciog@yahoo.com
Dr B R Desai
Jawaharlal Nehru Medical College, Belgaum
Prof and Head,
Jawaharlal Nehru Medical College
Jawaharlal Nehru Medical College
Belgaum 590010
Belgaum KARNATAKA
08312473777 08312470759 drbrdesai@yahoo.com
Dr Niranjan Mayadeo
KEM Hospital, Mumbai
Professor
Department of Obstetrics & Gynecology
Seth G. S. Medical College and K.E.M. Hospital, Parel,
Mumbai - 400012
Mumbai MAHARASHTRA
Director, Department of Obstetrics and Gynecology
TDH Building, first floor
KEM Hospital , Rasta Peth,
Pune - 411011
Pune MAHARASHTRA
02026124586 02026125603 kurus@pn2.vsnl.net.in
Dr Ragini Mehrotra
Medical College, Allahabad
Prof and HOD
Institute of Obstetrics and Gynecology,
Medical College,
Allahabad - 211002
Allahabad UTTAR PRADESH
05322256702
obgy2008@rediffmail.com
Dr Anushree Patil
NIRRH, Mumbai
Division of Clinical Research
second floor,
National Institute for Research in Reproductive Health, J M Street, Parel , Mumbai - 400012 Mumbai MAHARASHTRA
02224192030 02224139412 dir@nirrh.res.in
Dr Sushma Pandey
Patna Medical College, Patna
Prof and Head,
Dept of Obstetrics and Gynecology
Patna Medical College,
Patna - 800004
Patna BIHAR
06122670132 06122353411 drspandeypnh@yahoo.com
Dr L K Dhaliwal
PGIMER Chandigarh
Prof and HOD
Department of Obstetrics and Gynecology
Postgraduate Institute of Medical Education and Research,
Chandigarh - 160012
Chandigarh CHANDIGARH
01722756345 01722744401 dhaliwalgynae@yahoo.com
Dr Joydev Mukherjee
RG Kar Medical College, Kolkata
Prof and HOD
Institute of Obstetrics and Gynecology
R.G. Kar Medical College,
1, Belgachia Main Road, Kolkata - 700004
Kolkata WEST BENGAL
03325301673
joydevmukherji@gmail.com
Dr Shashi Prateek
Safdarjung Hospital & VMMC
Room No 162, first floor, OPD Block, Department of Obstetrics and Gynecology
Vardaman Mahavir Medical College and Safdarjung Hospital,
New Delhi - 110029
India New Delhi DELHI
01126707240 01126198108 shashiprateek@yahoo.com
Dr C Nirmala
SAT Medical College, Thiruvanathapuram
Room No 632
Prof and HOD
Department of Obstetrics and Gynecology
SAT Medical College
Thiruvanathapuram - 695011
Thiruvananthapuram KERALA
04712528362 04712448825 dr.nirmalac@gmail.com
Dr A K Behra
SCB Medical College, Cuttack
Prof and HOD
Institute of Obstetrics and Gynecology
SCB Medical College,
Cuttack- 753007
Cuttack ORISSA
06712418841 06712416913 directorhrrc@yahoo.com
Dr Vimla Jain
SMS Medical College and Mahila Chikitsalaya, Jaipur
Prof and Head
Department of Obstetrics and Gynecology
SMS Medical College and Mahila Chikitsalaya, Sanganeri Gate, Jaipur- 302004 Jaipur RAJASTHAN
01412205988 01412614498 hrrcjaipur@rediffmail.com
Details of Ethics Committee
No of Ethics Committees= 21
Name of Committee
Approval Status
Ethics Committee for research on human subjects,KEM Mumbai
Approved
Ethics Committee, GSVM Medical College, Kanpur
Approved
Ethics Committee, KLE University Belgaum
Approved
Ethics Committee, Patna Medical College
Approved
Ethics Committee,R.G.Kar Medical College, Kolkata
Approved
Human Ethics Committee, Thiruvananthapuram
Approved
ICMR Institutional Ethics Committee
Approved
Insitute Ethics Committe, AIIMS, New Delhi
Approved
Insitute Ethics Committe, CSMMU, Lucknow
Approved
Insitute Ethics Committe, Goa Medical College, Goa
Approved
Insitute Ethics Committe, Govt Medical College, Jammu
Approved
Insitute Ethics Committe, Grant Medical College, Mumbai
Approved
Insitute Ethics Committe, Medical College, Kolkata
Approved
Insitute Ethics Committe,KEM Hospital, Pune
Approved
Insitute Ethics Committe,SCB Medical College, Cuttack
Approved
Institute Ethics Committee, Allahabad
Approved
Institute Ethics Committee, Madras Medical College,Chennai
Approved
Institute Ethics Committee, PGIMER, Chandigarh
Approved
NIRRH Ethics Committee for Clinical Studies
Approved
Office of Ethics Committee, SMS Medical College, Jaipur
Approved
Office of Ethics Committee, VSSM and Safdarjung Hospital, Delhi
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Contraception
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Copper T 380 A
The Copper T380A IUD is registered in India and is used in the National Family Welfare Programme (NFWP) as a contraceptive method suitable for use by lactating and non-lactating women for a period of 10 years. HLL Lifecare provides IUD in the NFWP as Cu T 380A.It is available in the NFWP as the Copper T380A. However, the Copper T 380A IUD to be used in the study will be provided by HLL and HLL markets the product by the name T-CARE.
Intervention
Progesterone Vaginal Ring
PVR is comprised of a homogeneous distribution of progesterone (22.5% on a weight/weight basis; 2 gram total) in a silastic elastomer.It releases progesterone at an average rate of 10 mg per day over a 3-month (90-day) period maintaining the blood levels of progesterone to 10-25 nmol/L. Women enrolled in the study will receive a new PVR every 3 months for the duration of one year.
Inclusion Criteria
Age From
20.00 Year(s)
Age To
35.00 Year(s)
Gender
Female
Details
1. Able to provide informed consent
2. Age 20 to 35 years (inclusive)
3. Delivered a healthy singleton infant 6 to 9 weeks prior to study enrollment
4. Has at least one (1) living child and is exclusively breastfeeding the new infant
(no supplementary feedings)
5. The new breast fed infant’s weight is more than -2SD as per WHO weight for age standards
6. Experienced a normal post partum period
7. Is in good health as confirmed by medical history, physical examination (including vital signs), pelvic/breast examination, and results of laboratory tests at the screening visit
8. Willing to continue breastfeeding at least for one year
9. Has or expects to have regular exposure to the risk of pregnancy
10. Not currently using any method of contraception including barrier or conventional (abstinence, withdrawal, safe period) methods
11. Willing to be counseled on all methods of contraception & choose one study method (PVR/IUD)
12. Willing and able to follow study procedures & come to study center for study visits as described in the protocol
13. Expects to continue living in an area accessible to the study center for the duration of the study
ExclusionCriteria
Details
1. Are pregnant or are suspected of being pregnant
2. Giving supplementary feeds to the new infant
3. Clinically relevant genital prolapse
4. Had postpartum endometritis or puerperal sepsis
5. Had pelvic inflammatory disease or salpingitis since delivery
6. Are hypersensitive to hormonal preparations or silicone rubber
7. History of generalized urticaria
8. Any chronic condition requiring continuous or regular use of medication
9. Known or suspected diabetes or thyroid disease
10. History of thrombophlebitis or thromboembolism
11. Has a cerebrovascular disorder or coronary artery disease
12. History of and/or current incapacitating migraine
13. Confirmed hypertension or a history of severe pre-eclampsia
14. Neurovascular lesion of the eye or serious visual disturbance at screening
15. History of and/or current depression
16. History of epilepsy or convulsive disorder
17. Known or suspected hepatic adenomas or carcinomas
18. Had an ectopic pregnancy
19. Untreated acute cervicitis or vaginitis
20. Has vaginal bleeding not attributable to menses
21. Current Pap smear suggestive of high-grade pre-cancerous lesion(s), including HGSIL, CIN I and moderate or severe dysplasia
22. Known or suspected uterine or cervical malignancy
23. Known or suspected carcinoma of the breast
24. Has any other known or suspected neoplasia
25. Not cohabiting (not exposed to risk of pregnancy)
26. History of hepatitis or pregnancy-related jaundice
27. History of chronic constipation (for women who choose PVR only)
28. Use of chronic medications, Rifampicin, Griseofluvin, barbiturates, phenytoin, ketoconozole, butazoliden
29. Hemoglobin less than 8 g/dl (colorimeter method for cynmeth Hemoglobin )
30. Urine for albumin, sugar and microscopic examination indicates abnormal results
31. Blood Pressure- systolic more than 130 mm Hg and/or diastolic more than 85 mm Hg
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1.To confirm the contraceptive safety [inclusive of reports of adverse events (AEs) and serious adverse events (SAEs), results of medical examinations and laboratory safety studies] and efficacy (failure rate) of the progesterone vaginal ring (PVR) as compared to the Copper T 380A IUD in breastfeeding women during the first postpartum year.
2. To confirm and compare the continuation rate of PVR and the IUD in breastfeeding women during the first postpartum year.
First postpartum year.
Secondary Outcome
Outcome
TimePoints
1. infant growth (weight, length, WHO growth curve)
2. vaginal bleeding patterns (bleeding/spotting episodes)
3.duration of lactational amenorrhea
4. number of breastfeeding episodes, duration of full/partial nursing
5. tolerability (use problems, vaginal problems)
6. factors influencing decision making by nursing mothers to participate in a study with PVR, an investigational new contraceptive option, and the existing method Copper T 380A
First postpartum year
7. health care providers’ knowledge and attitudes about the methods and their use
8. factors influencing acceptability and perception of PVR and Copper T 380A
9. establish training in Good Clinical Practice and safety reporting
10. If results of the study are favorable, to assist in the transfer of PVR technology at the production scale to HLL in Trivandrum, India
First postpartum year
Target Sample Size
Total Sample Size="1600" Sample Size from India="1600" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This study is an open-label, multicentre trial to confirm the contraceptive efficacy, safety and acceptability of PVR releasing micronized progesterone (10 mg/day) and to compare the PVR with the Copper T380A intrauterine device (IUD) in breastfeeding women initiating use at 6 weeks postpartum.Approximately 1500 to 1600 exclusively breast feeding women who have selected the PVR or IUD as their contraceptive method, aged 20 to 35 years with normal healthy infants, wishing to continue breastfeeding for at least one year and meet all other eligibility criteria will participate at 20 ICMR study centers; approximately half the participants will use the PVR and half will use the IUD. Method use will begin at 6-9 weeks postpartum. Women selecting the PVR will use the method for 12 months or until weaning (fewer than 4 breast feeds per day); they will obtain a new PVR from the study center every 90 ± 5 days. At study end or weaning, they will be offered another contraceptive method of their choice, if desired. Women using the IUD may continue to use this method after weaning.Women will return to the study center for evaluations at 1 week, 1, 3, 6, 9, and 12 months or at weaning. After treatment, women using a contraceptive method or abstaining will be followed for 1 month; those wishing to become pregnant will be followed until pregnancy or up to 12 months, whichever comes first. The purpose of this project is to complete the development of a progesterone vaginal ring (PVR) that was shown to be effective in previous clinical studies to prolong lactational amenorrhea (LAM) and for the spacing of pregnancies. This technology could be of interest in many other countries including India as another contraceptive choice for spacing births. However there is a need to conduct studies in Indian women to evaluate the efficacy, safety and acceptability of this new method in this region. Other assessments will include demographic information, including age, body weight, height, education, socio-economic status, obstetric history of the mother and weight/length of the infant.