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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Endometriosis Pelvic Pain Dysmenorrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1 levonorgestrel IUD

Group Type ACTIVE_COMPARATOR

Levonorgestrel IUD

Intervention Type DEVICE

levonorgestrel IUD

2 control

Group Type NO_INTERVENTION

Levonorgestrel IUD

Intervention Type DEVICE

levonorgestrel IUD

Interventions

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Levonorgestrel IUD

levonorgestrel IUD

Intervention Type DEVICE

Other Intervention Names

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Minera IUD

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes