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

Last updated: March 1, 2011
Sponsor: Mahidol University
Overall Status: Completed

Phase

3

Condition

Female Hormonal Deficiencies/abnormalities

Severe Premenstrual Symptom

Menstrual Disorders

Treatment

N/A

Clinical Study ID

NCT00455845
15/2007
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • women diagnosed endometriosis stage I-IV according to the revised American Society ofReproductive Medicine classification

  • Moderate or severe pelvic pain or dysmenorrhea

  • Undergoing conservative laparoscopic surgery

Exclusion

Exclusion Criteria:

  • Patients who have uterine or adnexal anomalies other than endometriosis (chronicpelvic inflammatory disease, leiomyomas, endometrial polyps, genital malformations,pelvic varices)

  • using treatments for endometriosis other than paracetamol,nonsteroid anti-inflammatorydrugs 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 HealthOrganization (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

Study Design

Total Participants: 54
Study Start date:
April 01, 2007
Estimated Completion Date:
December 31, 2009

Study 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

Connect with a study center

  • Mahidol University

    Bangkoknoi, Bangkok 10700
    Thailand

    Site Not Available

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