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
  Purpose

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


Condition Intervention Phase
Endometriosis
Pelvic Pain
Dysmenorrhea
Device: Levonorgestrel IUD
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • the frequency and severity of pelvic pain or dysmenorrhea [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • compare about pain, bleeding, satisfaction and quality of life score between both groups [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 levonorgestrel IUD Device: Levonorgestrel IUD
levonorgestrel IUD
Other Name: Minera IUD
No Intervention: 2 control Device: Levonorgestrel IUD
levonorgestrel IUD
Other Name: Minera IUD

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455845

Locations
Thailand
Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Prasong Tanmahasamut, M.D. Mahidol University
  More Information

No publications provided by Mahidol University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Prof. Prasong Tanmahasamut, Mahidol University
ClinicalTrials.gov Identifier: NCT00455845     History of Changes
Other Study ID Numbers: 15/2007
Study First Received: April 3, 2007
Last Updated: March 1, 2011
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Mahidol University:
Endometriosis
Lng IUD

Additional relevant MeSH terms:
Dysmenorrhea
Endometriosis
Pelvic Pain
Menstruation Disturbances
Pathologic Processes
Pain
Signs and Symptoms
Genital Diseases, Female
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on September 15, 2014