To study safety and performance of Intrauterine Contraceptive Device.
- Conditions
- protection against pregnancy
- Registration Number
- CTRI/2022/09/045810
- Lead Sponsor
- PREGNA INTERNATIONAL LTD
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 357
Adult female of any reproductive age (21-45 years of age) Women who require contraception Women at high risk of pregnancy.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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.
Trial Locations
- Locations (2)
Dr.Radhikas Fertility and Surgical Center
🇮🇳Hyderabad, TELANGANA, India
Sri Clinic, Multispeciality Clinic
🇮🇳Hyderabad, TELANGANA, India
Dr.Radhikas Fertility and Surgical Center🇮🇳Hyderabad, TELANGANA, IndiaRADHIKA RANI AKKINENIPrincipal investigator9492810926draradhikarani@gmail.com