Levonorgestrel Intrauterine System and Adenomyosis

Can the Effect of Levonorgestrel Intrauterine System for Treatment of Adenomyosis be Predicted at Baseline Visit?

Adenomyosis is defined when the endometrial tissue (gland and stroma) is present within the myometrium . The depth of endometrial penetration which uses in diagnosis of adenomyosis not yet agreed; opinions range from one high power field to 25% of the myometrial thickness. It is a common condition in women aged 40-50 years and is considered an important cause of dysmenorrhea and menorrhagia in around 65 % of cases.

Until past few years; hysterectomy was the suggested definitive treatment, however; this may not be acceptable to women not willing to loss their fertility. Many treatment lines were studied and proved their beneficial effect on adenomyosis such as GnRH agonists, danazol, combined oral contraceptive pills, dienogest and finally endometrial ablation. However, these line of treatment are not commonly used because high incidence of side effects and relatively high cost of some of them.

The levonorgestrel-releasing intrauterine system (LNG-IUS) was emerged as an effective line for treatment of adenomyosis associated pain and bleeding. It can successfully, within 6 to 12 months, down-regulate the estrogen receptors in adenomyotic tissues which lead to decidualization and atrophy of the adenomyosis .

In fact, some adenomyotic women respond well to LNG-IUDs and show high acceptability and satisfaction, on the other hand; a group of women may not respond to LNG-IUDs and opt to remove it and start a new medical or surgical option for treatment.

However, factors related to LNG-IUS effectiveness in patients with adenomyosis were not well available. Only one report states that a large uterine volume could be a factor associated with LNG-IUS treatment discontinuation in adenomyotic patient.

For this reason; the prediction of the responsiveness to LNG-IUS is interesting issue which should be addressed. The present study examines the hypothesis that patient's data reported at baseline visit before using LNG-IUSfor controlling pain/bleeding with adenomyosis can help the prediction of the responsiveness for this important line of treatment at 6 months follow up visit. Up to our knowledge; no clinical trial had been registered or conducted to predict the responsiveness for LNG-IUS in controlling the pain/ bleeding with adenomyosis.

Study Overview

• Status: Completed
• Conditions: Adenomyosis
• Intervention / Treatment: Device: Levonorgestrel intrauterine system

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• adenomyosis
• request for contraception
• resident in the nearby vicinity to make the follow-up easy and feasible

Exclusion Criteria:

• history of ectopic pregnancy
• puerperal sepsis
• pelvic inflammatory disease
• evidence of coagulopathy
• abnormalities of the uterine cavity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Levonorgestrel intrauterine system	Device: Levonorgestrel intrauterine system; Levonorgestrel intrauterine system for adenomyosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of bleeding days per months	6 months
The degree of pain perception by visual analogue scale	6months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 7, 2017

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adenomyosis; 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_ADENO

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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