To study safety and performance of Intrauterine Contraceptive Device.

Phase 4

• Registration Number: CTRI/2022/09/045810
• Lead Sponsor: PREGNA INTERNATIONAL LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adult female of any reproductive age (21-45 years of age)

Women who require contraception

Women at high risk of pregnancy

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 Wilsonâ??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.Timepoint: 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 IUDâ??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.Timepoint: 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 IUDâ??s during these years. Duration of the study will be 5 years.