Levonorgestrel Intrauterine System and Adenomyosis

Adenomyosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104309
• Other study ID #: LNG_ADENO
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: April 13, 2017
• Start date: June 2015
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenomyosis

Intervention

Device:
• Levonorgestrel intrauterine system
Levonorgestrel intrauterine system for adenomyosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of bleeding days per months		6 months
Primary	The degree of pain perception by visual analogue scale		6months