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

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ClinicalTrials.gov Identifier: NCT00455845
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:
Mahidol University

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

Condition or disease Intervention/treatment Phase
Endometriosis Pelvic Pain Dysmenorrhea Device: Levonorgestrel IUD Phase 3

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. the frequency and severity of pelvic pain or dysmenorrhea [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. compare about pain, bleeding, satisfaction and quality of life score between both groups [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455845


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

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
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: April 2007

Keywords provided by Mahidol University:
Endometriosis
Lng IUD

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