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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00455845
First received: April 3, 2007
Last updated: March 1, 2011
Last verified: April 2007

April 3, 2007
March 1, 2011
April 2007
December 2009   (final data collection date for primary outcome measure)
the frequency and severity of pelvic pain or dysmenorrhea [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
the frequency and severity of pelvic pain or dysmenorrhea
Complete list of historical versions of study NCT00455845 on ClinicalTrials.gov Archive Site
compare about pain, bleeding, satisfaction and quality of life score between both groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
compare about pain, bleeding, satisfaction and quality of life score between both groups
Not Provided
Not Provided
 
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Endometriosis
  • Pelvic Pain
  • Dysmenorrhea
Device: Levonorgestrel IUD
levonorgestrel IUD
Other Name: Minera IUD
  • Active Comparator: 1 levonorgestrel IUD
    Intervention: Device: Levonorgestrel IUD
  • No Intervention: 2 control
    Intervention: Device: Levonorgestrel IUD
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00455845
15/2007
No
Associate Prof. Prasong Tanmahasamut, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Prasong Tanmahasamut, M.D. Mahidol University
Mahidol University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP