Try our beta test site

Maintenance Therapy of Levonorgestrel-releasing Intrauterine System (LNG-IUS) to Prevent the Recurrence of Symptomatic Endometriosis After Conservative Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
Information provided by:
Taipei Veterans General Hospital, Taiwan Identifier:
First received: April 26, 2010
Last updated: June 6, 2010
Last verified: June 2010

The recurrence rates of endometriosis reported in women 5 years after therapy with gonadotropin releasing hormone (GnRH) agonist were 74% for severe disease . No strategies to prevent the recurrence of endometriosis have been uniformly successful. Local progesterone treatment of endometriosis-associated dysmenorrhea with a levonorgestrel-releasing intrauterine system (LNG-IUS) for 12 months has resulted in a significant reduction in dysmenorrhea, pelvic pain and dyspareunia; a high degree of patient satisfaction; and a significant reduction in the volume of rectovaginal endometriotic nodules. LNG-IUS may become a more important option if a long-term medical suppression of endometriosis.

Based on literature review, I hypothesized that maintenance therapy of LNG-IUS in conjunction with the GnRH agonist could lower the recurrence rates endometriosis after conservative surgery. We try to answer the question whether maintenance therapy of LNG-IUS in conjunction with the GnRH agonist could lower the recurrence rates and thus extend the symptom-free interval (menorrhagia and dysmenorrhea) as compared to GnRH agonist alone after conservative surgery in severe endometriosis cases.

Condition Intervention Phase
Device: LNG-IUS
Drug: GnRH agonist (triptorelin)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Maintenance Therapy of LNG-IUS in Conjunction With the GnRH Agonist to Prevent the Recurrence of Symptomatic Endometriosis After Conservative Surgery: A Prospective Randomized, Phase III Trial

Resource links provided by NLM:

Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • Recurrence rate of endometriosis [ Time Frame: 2 years ]
    We will follow the patients for 2 years, after the end of GnRH agonist medical treatment. Number of Participants with recurrence as a Measure of the clinical efficacy of LNG-IUS maintenance therapy to prevent recurrence of endometriosis.

Secondary Outcome Measures:
  • the safety of LNG-IUS maintenance therapy to prevent recurrence of endometriosis. [ Time Frame: 2 years ]
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

Estimated Enrollment: 80
Study Start Date: March 2008
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LNG-IUS
LNG-IUS insertion during conservative surgery and GnRH agonist 6 doses.
Device: LNG-IUS
levonorgestrel-releasing intrauterine system (LNG-IUS) 52mg, duration 5 years
Other Name: mirena
Drug: GnRH agonist (triptorelin)
GnRH agonist (triptorelin 3.75 mg, sc q28day)
Active Comparator: GnRH agonist
The second group of patients receive GnRH agonist (triptorelin 3.75 mg, sc q28day) alone for 24 weeks.
Drug: GnRH agonist (triptorelin)
GnRH agonist (triptorelin 3.75 mg, sc q28day)

  Show Detailed Description


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with moderate-severe symptomatic endometriosis (rASRM score >16) according to the American Society for Reproductive Medicine) or adenomyosis. Symptomatic endometriosis means menorrhagia or dysmenorrhea.
  • All patients were surgically treated by a conservative approach.
  • Levels of serum CA125 is higher than normal range.

Exclusion Criteria:

  • Further desire for child bearing in future 3 years.
  • Any treatment for endometriosis within the previous 2 months.
  • Any concomitant disease that can be an established cause of chronic pelvic pain and anemia (Thalassemia anemia, inflammation sequela, myoma , and pelvic congestion etc)
  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 identifier: NCT01125488

Taipei Veterans Genreal Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Principal Investigator: Yi-Jen Chen, MD Department OBS & GYN, Taipei Veterans General Hospital
  More Information

Responsible Party: Yi-Jen Chen MD, Department of Obstetrics & Gynecology,Taipei Veterans General Hospital,Taiwan Identifier: NCT01125488     History of Changes
Other Study ID Numbers: VGHIRB 97-04-03 
Study First Received: April 26, 2010
Last Updated: June 6, 2010

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Maintenance therapy

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Genital Diseases, Female
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Synthetic
Contraceptives, Oral processed this record on February 20, 2017