The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis

March 1, 2011 updated by: Mahidol University

A Double Blind Randomized Controlled Trial to Study the Effectiveness of a Levonorgestrel Releasing Intrauterine Device for the Treatment of Pelvic Pain or Dysmenorrhea in the Patients Undergone Conservative Surgery for Pelvic Endometriosis

this study is to determine whether the frequency and severity of pelvic pain or dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endometriosis is a common cause of chronic pelvic pain.Laparoscopic surgery is often the treatment of choice for symptomatic disease and results are usually satisfactory but symptoms recur in 10-20% of treated women per year. Postoperative medical therapy has been controversial. Whereas some studies have observed a long pain free interval or higher pregnancy rates when surgical treatment is followed by an interval of medical suppressive treatment, numerous others have found no differences between the prevalence of recurrent pain or pregnancy rates 1-3 years after surgery treatment in women who did and did not receive postoperative medical treatment.Endometriosis is generally a localized disease but is currently managed with systemic medical therapies. The use of drugs administered locally and specifically aimed at pelvic organs could limit the metabolic impact without reducing antalgic efficacy.An intrauterine device releasing levonorgestrel, a potent 19-nortestosterone derivative progestin, can induce amenorrhea with a different modality with respect to standard regimens. The levonorgestrel intrauterine device (Lng-IUD) provides an alternative means of administering progestins.Some researchers reported the effectiveness of the Lng IUD in the patients with endometriosis.The primary objective of this study is to determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a Lng IUD is inserted after operative laparoscopy compare with those treated with laparoscopic surgery only.

The secondary objective is to compare about pain, bleeding, satisfaction and quality of life score between both groups

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women diagnosed endometriosis stage I-IV according to the revised American Society of Reproductive Medicine classification
  • Moderate or severe pelvic pain or dysmenorrhea
  • Undergoing conservative laparoscopic surgery

Exclusion Criteria:

  • Patients who have uterine or adnexal anomalies other than endometriosis (chronic pelvic inflammatory disease, leiomyomas, endometrial polyps, genital malformations, pelvic varices)
  • using treatments for endometriosis other than paracetamol,nonsteroid anti-inflammatory drugs or narcotic derivative in the 3 months before study entry
  • Unable to perform conservative surgery
  • Patients who have contraindications to Lng IUD as defined by the World Health Organization (2004).
  • Patients who are unwilling to tolerate menstrual changes.
  • Plan to have children within 1 year
  • Unable to evaluate pain with visual analogue scale
  • unwilling to participate this project

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 levonorgestrel IUD
Device: Levonorgestrel IUD
levonorgestrel IUD
Other Names:
  • Minera IUD
No Intervention: 2 control
Device: Levonorgestrel IUD
levonorgestrel IUD
Other Names:
  • Minera IUD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the frequency and severity of pelvic pain or dysmenorrhea
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
compare about pain, bleeding, satisfaction and quality of life score between both groups
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Prasong Tanmahasamut, M.D., Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 3, 2007

First Submitted That Met QC Criteria

April 3, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Estimate)

March 2, 2011

Last Update Submitted That Met QC Criteria

March 1, 2011

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometriosis

Clinical Trials on Levonorgestrel IUD

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe