The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis
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
1 other identifier
interventional
54
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2007
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 3, 2007
CompletedFirst Posted
Study publicly available on registry
April 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMarch 2, 2011
April 1, 2007
2.7 years
April 3, 2007
March 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the frequency and severity of pelvic pain or dysmenorrhea
12 months
Secondary Outcomes (1)
compare about pain, bleeding, satisfaction and quality of life score between both groups
12 months
Study Arms (2)
1 levonorgestrel IUD
ACTIVE COMPARATOR2 control
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mahidol University
Bangkoknoi, Bangkok, 10700, Thailand
Related Publications (1)
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.
PMID: 22314873DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prasong Tanmahasamut, M.D.
Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 3, 2007
First Posted
April 4, 2007
Study Start
April 1, 2007
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
March 2, 2011
Record last verified: 2007-04