Levonorgestrel Intrauterine System and Adenomyosis
Primary Purpose
Adenomyosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Levonorgestrel intrauterine system
Sponsored by
About this trial
This is an interventional treatment trial for Adenomyosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Levonorgestrel intrauterine system
Arm Description
Outcomes
Primary Outcome Measures
number of bleeding days per months
The degree of pain perception by visual analogue scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03104309
Brief Title
Levonorgestrel Intrauterine System and Adenomyosis
Official Title
Can the Effect of Levonorgestrel Intrauterine System for Treatment of Adenomyosis be Predicted at Baseline Visit?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomyosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levonorgestrel intrauterine system
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Levonorgestrel intrauterine system
Intervention Description
Levonorgestrel intrauterine system for adenomyosis
Primary Outcome Measure Information:
Title
number of bleeding days per months
Time Frame
6 months
Title
The degree of pain perception by visual analogue scale
Time Frame
6months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Levonorgestrel Intrauterine System and Adenomyosis
We'll reach out to this number within 24 hrs