Levonorgestrel-releasing Intrauterine System and Tubal Ligation

Levonorgestrel-releasing Intrauterine System: A Emerging Tool for Conservative Treatment of Pain and Bleeding After Tubal Ligation

Today tubal sterilization is a simple, safe, and cost-effective method of achieving long-term contraception. Sterilization is an ideal method of permanent contraception in developing countries where access to health care providers is limited. The percentage of women who use sterilization as a method of contraception rises from about 5% between 20 and 24 years of age to almost 50% for those between 40 and 44 years of age. The most widely touted and most significant health benefit of tubal sterilization appears to be a reduced risk of ovarian cancer.

Post-tubal ligation syndrome includes pain during intercourse, aching lower back, premenstrual tension syndrome, uterine hemorrhage, and absence of menstruation. The syndrome is caused by blood circulation problems in and around the Fallopian tubes and ovaries, pressure on nerves, and intrapelvic adhesion. Since the symptoms of this syndrome are mild, simple symptomatic treatment is sufficient in most cases. In some cases, however, hysterectomy may be necessary.

Study Overview

• Status: Terminated
• Conditions: Tubal Ligation
• Intervention / Treatment: Device: Levonorgestrel-releasing intrauterine system

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Women Health Hospital - Assiut university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women aged from 30-40 year
• Woman subjected to tubal ligation
• Women 12 month postpartum
• Non lactating women
• Nomedical disorders

Exclusion Criteria:

• contraindication for Levonorgestrel-releasing Intrauterine System
• Women with any uterine or ovarian pathology
• women refuse to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Levonorgestrel-releasing intrauterine system	Device: Levonorgestrel-releasing intrauterine system; Levonorgestrel-releasing intrauterine system will be inserted during the menstrual cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The level of pain from before to 6 months after levonorgestrel-releasing intrauterine system insertion	visual analogue scale from 0 (minimum value) to 10 (maximum value)	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: December 5, 2020
• First Submitted That Met QC Criteria: December 5, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptives, Oral, Synthetic; Levonorgestrel
• Other Study ID Numbers: LNG_TS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No