| CTRI Number |
CTRI/2011/11/002110 [Registered on: 08/11/2011] Trial Registered Prospectively |
| Last Modified On: |
28/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Contraceptive vaginal ring releasing etonogestrel and ethinylestradiol (NuvaRing): Study of the use of a contraceptive vaginal ring (NuvaRing) in normal daily practice in Indian women |
|
Scientific Title of Study
|
Contraceptive vaginal ring releasing etonogestrel and ethinylestradiol (NuvaRing): Cycle control, acceptability and tolerability study in Indian women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| P07733 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Viraj Salgoankar |
| Designation |
Director Medical Affairs |
| Affiliation |
MSD Pharmaceutical Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd
Platina Building, 10th Floor
C-59, G-Block,
Bandra Kurla Complex
Bandra (East)
Mumbai 400098, India
Mumbai
MAHARASHTRA
400098
India |
| Phone |
91-22-6789-8888 |
| Fax |
91-22-6789-8889 |
| Email |
viraj.salgaonkar@merck.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Viraj Salgoankar |
| Designation |
Director Medical Affairs |
| Affiliation |
MSD Pharmaceutical Pvt Ltd |
| Address |
MSD Pharmaceuticals Pvt Ltd
Platina Building, 10th Floor
C-59, G-Block,
Bandra Kurla Complex
Bandra (East)
Mumbai 400098, India
Mumbai (Suburban)
MAHARASHTRA
400098
India |
| Phone |
91-22-6789-8888 |
| Fax |
91-22-6789-8889 |
| Email |
viraj.salgaonkar@merck.com |
|
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Source of Monetary or Material Support
|
| Merck Sharp & Dohme
One Merck Drive P.O. Box 100
Whitehouse Station, NJ 08889-0100 USA |
|
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Primary Sponsor
|
| Name |
Merck Sharp and Dohme |
| Address |
One Merck Drive P.O. Box 100 Whitehouse Station, NJ 08889-0100 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Organon India Limited a subsidiary of Merck and Co Inc Whitehouse Station NJ USA |
Saturday Club Building, 7,
Wood Street, Kolkata-700016 |
|
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Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijayalakshmi R |
Bangalore Clinisearch |
No 416,4th Cross,2nd Block,Kalyan Nagar 56003
Bangalore
KARNATAKA |
91-8025458990
91-02230972030
dr_vijayalakshmi@hotmail.com |
| Dr Bharti Kalra |
Bharti Hospital |
Wazir Chand Colony, Kunjpura Road, Karnal - 132 001, Haryana, India
Karnal
HARYANA |
91-184-2268484
brideknl@gmail.com |
| Dr Suchitra Pandit |
Kokilaben Dhirubhai Ambani Hospital |
Department of Obstetrics & Gynaecology, Kokilaben Dhirubhai Ambani Hospital, Rao Saheb Achutrao Patwardhan Marg, Four Bunglows,
Andheri (W), Mumbai - 400053
Mumbai
MAHARASHTRA |
9820416474
suchitra.pandit@relianceada.com |
| Dr Shuchita Meherishi |
Mahatma Gandhi Medical College and Hospital |
Department of Obstetrics and Gynecology MAMC, Delhi - Department of Obstertrics and Gynecology - RIICO Institutional Area, Sitapura, Tonk Road, Jaipur - 302 022, Rajasthan, India
Jaipur
RAJASTHAN |
911412771777
shuchitame@gmail.com |
| Dr Ashok Kumar |
Maulana Azad Medical College associated Lok Nayak Hospital |
Maulana Azad Medical College associated Lok Nayak Hospital, New-Delhi - 110 002, India.
Central
DELHI |
91-11-23235823
ash64kr@yahoo.com |
| Dr Anahita Chauhan |
Seth G. S. Medical Collge & KEM Hospital |
Department of Obstetrics & Gynaecology, Seth G. S. Medical Collge & KEM Hospital, A. Donde Marg, Parel-Mumbai – 400 012,
Mumbai
MAHARASHTRA |
912224107000
anahitachauhan@gmail.com |
| Dr Sanjeeva Reddy |
Shri Ramchandra Medical College & Research Institute |
Department of Obstetrics & Gynaecology,Shri Ramchandra Medical College & Research Institute, No. 1 Ramchandra Marg, Porur, Chennai - 600 116
Chennai
TAMIL NADU |
91-44-45928326
royalnsr@yahoo.com |
| Dr Manjula Anagani |
Yashoda Hospital |
Raj Bhavan Road, Samajiguda, Hyderabad – 500082, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
91-9848030121
manjuanagani@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee-Bangalore Dr Vijayalakshmi |
Approved |
| Bharti Research Institute of Diabetes and Endocrinology BRIDE Institutional Ethics Committee |
Approved |
| Ethics Committee for Research on Human Subjects (ECRHS)-KEMS hospital |
Approved |
| Ethics Committee- Maulana Azad Medical College associated Lok Nayak Hospital |
Submittted/Under Review |
| Institutional EC-Yashoda Academy of Medical Education and Research |
Approved |
| Institutional ethics Committee, Mahatma Gandhi Medical College & Hospital |
Approved |
| Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
Approved |
| SRI Ramachandra Univiversity Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Contraception |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing) |
Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
There is no upper age limit specified for this study
Women at risk of pregnancy and seeking contraception |
|
| ExclusionCriteria |
| Details |
Exclusion criteria based on approved prescribing information in India:
Presence or history of venous thrombosis, with or without pulmonary embolism.
Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or
transient ischemic attack).
Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).
History of migraine with focal neurological symptoms.
Diabetes mellitus with vascular involvement.
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors)
Pancreatitis or a history thereof if associated with severe hypertriglyceridemia.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Presence or history of liver tumors (benign or malignant).
Known or suspected malignant conditions of the genital organs or the breasts, if sex steroid-influenced.
Undiagnosed vaginal bleeding.
Known or suspected pregnancy.
Hypersensitivity to the active substances or to any of the excipients of NuvaRing.
Women who are breast feeding |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
-Participants with regular menstrual cycles
-Participants with breakthrough bleeding/spotting
-Average number of bleeding days, pads used per day and bleeding/spotting days
-Assessment of ease of insertion and removal
-Frequency of feeling ring at any time or during intercourse
-Frequency of partner feeling ring during intercourse or of objection to ring use
-Participants overall satisfaction with ring
-Participants who plan to continue use of ring
-Participants who would recommend ring |
3 cycles (1 cycle is 28 days) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Number of pregnancy or pregnancies due to contraceptive method failure during the study |
3 cycles (1 cycle is 28 days) |
| Number of adverse events reported during the study |
3 cycles (1 cycle is 28 days) |
| Number of serious adverse events during the study |
3 cycles (1 cycle is 28 days) |
|
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Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
31/12/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study will collect information on cycle control, acceptability and tolerability of the vaginal contraceptive ring (NuvaRing) as used in normal daily practice by Indian women. |