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The Effectiveness of Lng IUD for Treatment of the Patient Undergone Conservative Surgery for Pelvic Endometriosis
This study is currently recruiting participants.
Verified by Mahidol University, April 2007
First Received: April 3, 2007   Last Updated: April 26, 2009   History of Changes
Sponsored by: Mahidol University
Information provided by: Mahidol University
ClinicalTrials.gov Identifier: NCT00455845
  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 III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 levonorgestrel IUD: Active Comparator Device: Levonorgestrel IUD
levonorgestrel IUD
2 control: No Intervention Device: Levonorgestrel IUD
levonorgestrel 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455845

Contacts
Contact: Prasong Tanmahasamut, M.D. 6624197000 ext 4657 prasong98@gmail.com
Contact: Manee Rattanachaiyanont, M.D. 6624197000 ext 4657 sirmt@mahidol.ac.th

Locations
Thailand, Bangkok
Mahidol University Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Prasong Tanmahasamut, Doctor     6624197000 ext 4657     prasong98@gmail.com    
Contact: Manee Rattanachaiyanont, Doctor     6624197000 ext 4657     simrt@mahidol.ac.th    
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Prasong Tanmahasamut, M.D. Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University ( Associate Prof. Prasong Tanmahasamut )
Study ID Numbers: 15/2007
Study First Received: April 3, 2007
Last Updated: April 26, 2009
ClinicalTrials.gov Identifier: NCT00455845     History of Changes
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Mahidol University:
Endometriosis
Lng IUD

Study placed in the following topic categories:
Genital Diseases, Female
Signs and Symptoms
Pelvic Pain
Menstruation Disturbances
Dysmenorrhea
Contraceptive Agents
Levonorgestrel
Contraceptives, Oral
Contraceptive Agents, Female
Endometriosis
Pain

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

ClinicalTrials.gov processed this record on September 10, 2009