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Immediate Versus Delayed Initiation of Intrauterine System

NCT03708809 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-11-14

No results posted yet for this study

Summary

Contraception for teenagers and young adults presents a huge challenge for the clinician as more than half of all unintended pregnancies occur as a result of inconsistent or discontinued use of contraceptives . Possible solution is promoting the use of long acting reversible contraception, (LARC) among them the intrauterine device (IUD). IUD provide safe, highly effective, long-term contraception. Immediate IUD insertion after the termination of pregnancy (TOP) is a very convenient way to provide contraception as it is an opportune moment to carry out this short, easy, and safe procedure.

Janess is a T-shaped intrauterine delivery system that was introduced lately, which slowly releases a small amount (13.5 mg) of levonorgestrel after its installation inside the womb and provides contraception for up to three years.

The aim of this study to compare insertion of 13.5 mg levonorgestrel-releasing intrauterine system after surgical abortion immediately versus delayed insertion (at menstruation)

Conditions

  • Contraception

Interventions

DEVICE

Intrauterine system

13.5 mg levonorgestrel-releasing intrauterine system

OTHER

Alternative contraception to intrauterine system

Alternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring,

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Sheba Medical Center

    lead OTHER_GOV

Principal Investigators

  • Aya Mohr Sasson, M.D · Sheba Medical Center, Tel-Hashomer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-08-01
Completion
2026-08-01
FDA Device
Yes

Countries

  • Israel

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03708809 on ClinicalTrials.gov