Clinical trial NCT00455845: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endometriosis
Pelvic Pain
Dysmenorrhea
Keywords: Endometriosis
Lng IUD
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2007-04-04
Enrollment: 54
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: the frequency and severity of pelvic pain or dysmenorrhea
timeFrame: 12 months
Secondary outcomes:
measure: compare about pain, bleeding, satisfaction and quality of life score between both groups
timeFrame: 12 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Prasong Tanmahasamut, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.