Contraceptive and Non Contraceptive Effects of LNG IUS (ELOIRA)

Not Applicable

Not yet recruiting

• Registration Number: CTRI/2020/09/027790
• Lead Sponsor: Pregna International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Parous and nulliparous women choosing LNG IUS for interval contraception after Cafetaria method with GATHER approach,

2. Willing to participate in the study

Exclusion Criteria

1 .Known or suspected Pregnancy

2. Current Pelvic infection

3. Uterine bleeding of unknown etiology,

4. Post renal transplant patients

5. Acute liver disease or liver tumor (benign or malignant)

6. Known or suspected uterine or cervical neoplasia

7. Chorio-carcinoma patients on follow-up

8. Subjects at increased risk for infectious endocarditis (prosthetic heart valves, rheumatic heart disease, previous endocarditis)

9. Women with a prior Tubectomy/trans cervical tubal sterilization procedure (e.g., Essure)

10. Postmenopausal woman

11. Use of another hormonal contraceptive within 30 days of levonorgestrel intrauterine system placement for the study

12. Vaginal delivery, cesarean delivery, or abortion within six weeks prior to levonorgestrel intrauterine system insertion (uterus should be fully involuted before insertion).

13. Women with a uterine cavity that measures less than 6 cm or greater than 10 cm

14. Congenital or acquired uterine anomaly, including fibroids if they distort the uterine cavity

15. Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy

16. Postpartum endometritis or infected abortion in the past 3 months

17. Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past

18. Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections

19. Conditions associated with increased susceptibility to pelvic infections

20. A previously inserted intrauterine device that has not been removed

21. Hypersensitivity to any component of the product

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate contraceptive efficacy of LNG IUS (Eloira)Timepoint: Phase I â?? Consenting and Screening phase. <br/ ><br>Phase II â?? Insertion phase <br/ ><br>Phase III â?? Follow up phase (5 years)

Secondary Outcome Measures

Name	Time	Method
To evaluate following factors in women using LNG IUS (Eloira) <br/ ><br>1.Uterine Artery pattern and endometrial thickness as per Doppler scan <br/ ><br>2.Changes in menstrual bleeding pattern <br/ ><br>3.Changes in menstrual pain <br/ ><br>4.Expulsion rate <br/ ><br>5.Incidence of adverse events <br/ ><br>6.Ectopic pregnancies with Eloira <br/ ><br>7.Evaluate improvement in Hemoglobin level <br/ ><br>8.Any change in serum lipid profile <br/ ><br>9.Measure serum Levonorgestral levelTimepoint: Outcomes will be assessed at <br/ ><br>1 Month <br/ ><br>3 month <br/ ><br>6 Months <br/ ><br>1 year <br/ ><br>2year <br/ ><br>3 year <br/ ><br>4 year <br/ ><br>5 year <br/ ><br> <br/ ><br>for Nulliparous women <br/ ><br>1 month <br/ ><br>3 month <br/ ><br>6 month <br/ ><br>1 year