The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis
Primary Purpose
Endometriosis, Pelvic Pain, Dysmenorrhea
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Levonorgestrel IUD
Sponsored by
About this trial
This is an interventional prevention trial for Endometriosis focused on measuring Endometriosis, Lng IUD
Eligibility Criteria
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
Sites / Locations
- Mahidol University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
1 levonorgestrel IUD
2 control
Arm Description
Outcomes
Primary Outcome Measures
the frequency and severity of pelvic pain or dysmenorrhea
Secondary Outcome Measures
compare about pain, bleeding, satisfaction and quality of life score between both groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00455845
Brief Title
The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Pelvic Pain, Dysmenorrhea
Keywords
Endometriosis, Lng IUD
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 levonorgestrel IUD
Arm Type
Active Comparator
Arm Title
2 control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Levonorgestrel IUD
Other Intervention Name(s)
Minera IUD
Intervention Description
levonorgestrel IUD
Primary Outcome Measure Information:
Title
the frequency and severity of pelvic pain or dysmenorrhea
Time Frame
12 months
Secondary Outcome Measure Information:
Title
compare about pain, bleeding, satisfaction and quality of life score between both groups
Time Frame
12 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prasong Tanmahasamut, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
22314873
Citation
Tanmahasamut P, Rattanachaiyanont M, Angsuwathana S, Techatraisak K, Indhavivadhana S, Leerasiri P. Postoperative levonorgestrel-releasing intrauterine system for pelvic endometriosis-related pain: a randomized controlled trial. Obstet Gynecol. 2012 Mar;119(3):519-26. doi: 10.1097/AOG.0b013e31824264c3.
Results Reference
derived
Learn more about this trial
The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis
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