| CTRI Number |
CTRI/2022/09/045810 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study safety and performance of Intrauterine Contraceptive Device. |
|
Scientific Title of Study
|
Single arm, Open label, Multicentre, Prospective Observational study to evaluate safety and performance of Intrauterine Contraceptive Device |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Prasanna |
| Designation |
Laparoscopic Surgeon (Obs & Gyn), Gynecologist |
| Affiliation |
gynaecologist & Obstetrician at Sri Clinic, Hyderabad |
| Address |
Sri Clinic, Multispeciality Clinic LIG 233 &234, S.R Residency, 7th Phase, KPBH Colony, Kukatpally, Hyderabad, Telegana-500 072
Hyderabad
TELANGANA
500072
India |
| Phone |
9949132433 |
| Fax |
|
| Email |
Lakshmiyadavalli2008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshmi Prasanna |
| Designation |
Laparoscopic Surgeon (Obs & Gyn), Gynecologist |
| Affiliation |
gynaecologist & Obstetrician at Sri Clinic, Hyderabad |
| Address |
Sri Clinic, Multispeciality Clinic LIG 233 &234, S.R Residency, 7th Phase, KPBH Colony, Kukatpally, Hyderabad, Telegana-500 072
Hyderabad
TELANGANA
500072
India |
| Phone |
9949132433 |
| Fax |
|
| Email |
Lakshmiyadavalli2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Prasanna |
| Designation |
Laparoscopic Surgeon (Obs & Gyn), Gynecologist |
| Affiliation |
gynaecologist & Obstetrician at Sri Clinic, Hyderabad |
| Address |
Sri Clinic, Multispeciality Clinic LIG 233 &234, S.R Residency, 7th Phase, KPBH Colony, Kukatpally, Hyderabad, Telegana-500 072
Hyderabad
TELANGANA
500072
India |
| Phone |
9949132433 |
| Fax |
|
| Email |
Lakshmiyadavalli2008@gmail.com |
|
|
Source of Monetary or Material Support
|
| PREGNA INTERNATIONAL LTD Plot No. 219, Survey No. 168, Dabhel Co. Op. Ind. Soc. Ltd., Dabhel, Daman (U.T.)- 396210, India website:www.pregna.com |
|
|
Primary Sponsor
|
| Name |
PREGNA INTERNATIONAL LTD |
| Address |
Plot No.219, Survey No. 168, Dabhel Co. Op. Ind. Soc. Ltd., Dabhel, Daman (U.T.)- 396210, India.website: www.pregna.com |
| Type of Sponsor |
Other [Manufacturing company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| RADHIKA RANI AKKINENI |
Dr.Radhikas Fertility and Surgical Center |
Room no -2,2nd floor,Park View Apartments, MIG 15-25, Rd Number 1, opp. GHMC park, Kukatpally Housing Board Colony, Kukatpally Hyderabad, Telangana 500085
Hyderabad
TELANGANA |
9492810926
draradhikarani@gmail.com |
| Dr Lakshmi Prasanna |
Sri Clinic, Multispeciality Clinic |
Room no.1,Ground floor,LIG 233 &234, S.R Residency, 7th Phase, KPBH Colony, Kukatpally, Hyderabad, Telegana-500072
Hyderabad
TELANGANA |
9949132433
Lakshmiyadavalli2008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Deccan Independent Ethics Committee |
Approved |
| Deccan Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
protection against pregnancy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Adult female of any reproductive age (21-45 years of age)
Women who require contraception
Women at high risk of pregnancy |
|
| ExclusionCriteria |
| Details |
Subjects with malignant diseases of the genital tract
Subjects with undiagnosed vaginal bleeding - Subjects who are pregnant
Subjects with past history of ectopic pregnancy or predisposing factors.
Subjects with infections of the genital tract
Subjects with sexually transmitted diseases during the last 12 months (except bacterial vaginitis, repeated herpes infection, Hepatitis B)
Subjects with abortion with infection during the last 3 months, pelvic inflammatory disease
Subjects with uterine malformations (congenital or acquired)
Subjects with allergy to copper
Subjects with Anemia
Subjects with valvular heart disease
Subjects with coagulation disorders
Subjects with anti-inflammatory treatment - Subjects with Wilson’s disease
Subjects with multiple exposures to different sexual partners
Subject not willing for IUD insertion. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective of this post market clinical study is to assess the clinical performance and safety of the Intrauterine Contraceptive Device. Duration of the study will be 5 year. |
There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year.During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD’s during these years. Duration of the study will be 5 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device. |
There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year.During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD’s during these years. Duration of the study will be 5 years. |
|
|
Target Sample Size
|
Total Sample Size="357"
Sample Size from India="357"
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)
|
26/09/2022 |
| 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="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Single arm, Open label, Multicentre, Prospective Observational study to evaluate safety and performance of Intrauterine Contraceptive Device. The purpose of the study is to evaluate safety and performance of Intrauterine Contraceptive Device and to determine the adverse events or complications related to the use of the device. The primary objective of this post market clinical study is to assess the clinical performance and safety of the Intrauterine Contraceptive Device . The Secondary Objective is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device. Study Design: Single arm, Multi centre, open-label, observational, prospective clinical study Subjects will be fully explained about the study and signed informed consent will be taken. The subjects who met the inclusion criteria will be enrolled for the study. The rates of complications during insertion, the efficacy in preventing pregnancy and other complications related to IUD will be assessed through Case Report Forms. There will be six follow up visits after the insertion of IUD after one month, 1st year, 2nd year, 3rd year, 4th year and 5th year. During the follow up visit of one year, second year, third year, fourth year and fifth year the reversible fertility condition also will be verified in those subjects who had removed the IUD’s during these years. The primary endpoint of this post market clinical study is to assess the clinical performance and safety of the Intrauterine Contraceptive Device. Efficiency in preventing pregnancy Any case of IUD removal Any case discontinuation of IUD’s Any case of switching to other contraceptive method The Secondary Endpoint is to determine any undesirable events under normal condition of use and identify the presence of any new emergent risks, known and unknown residual risk. The study will focus on identifying possible systematic misuse or off-label use of the device. The duration of the study will be 5 years. There will be six follow up visit for every subject After one month of IUD implantation Last month of that year of IUD implantation was done Second Year Third Year Fourth Year Fifth Year Inclusion Criteria
Adult female of any reproductive age (21-45 years of age) - Women at high risk of Pregnancy Women requiring contraception Exclusion Criteria Subjects with malignant diseases of the genital tract - Subjects with undiagnosed vaginal bleeding - Subjects who are pregnant - Subjects with past history of ectopic pregnancy or predisposing factors. - Subjects with infections of the genital tract Subjects with sexually transmitted diseases during the last 12 months (except bacterial vaginitis, - repeated herpes infection, Hepatitis B) Subjects with abortion with infection during the last 3 months, pelvic inflammatory disease Subjects with uterine malformations (congenital or acquired) Subjects with allergy to copper Subjects with Anemia Subjects with valvular heart disease Subjects with coagulation disorders Subjects with anti-inflammatory treatment Subjects with Wilson’s disease Subjects with multiple exposures to different sexual partners |